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Found 25 results
510(k) Data Aggregation
(315 days)
Medispine - Spinal Needle, Glospine - Spinal Needle
Spinal Needle (Quincke Bevel and Pencil Point) is intended for injection of local anesthetics into the subarachnoid space to provide spinal anesthesia for pain management. The device is intended to be used in a professional healthcare environment and not tested for MRI safety.
Spinal Needles are long, flexible needles of small gauge (typically 18G to 27G) which are available with different types of tips: Pencil point and Quincke bevel. The Spinal Needles are available in a series of combination of needle size and length. The smaller size needles of Pencil point tip are provided with introducer needles to provide support for accessing the tough tissues. Spinal needles have a removable stylet that completely occludes the lumen to avoid block. The stylet is withdrawn after the spinal anesthesia needle has penetrated into the subarachnoid space for injecting anesthetic. The needle hub is luer connector (6% luer taper).
The provided text is a 510(k) premarket notification for a medical device (Spinal Needle). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than describing an AI/ML algorithm's performance. As such, it does not contain the information required to answer the prompt regarding acceptance criteria and performance studies for an AI/ML device.
Specifically, the document states: "No clinical data was included in this premarket application submission." and the detailed sections relate to physical and chemical properties, sterilization, and material compatibility, not AI system performance.
Therefore, I cannot provide the requested information from the given text.
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(265 days)
BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle
The BD™ Spinal Needles are intended to gain entry into or puncher the spinal cavity permitting injection (including anesthesia)/withdrawal of fluids for purposes of diagnostic lumbar puncture and myelography procedures.
This device is intended for adult and pediatric patients.
The BD™ Spinal Introducer Needle is intended for placement or introduction of spinal needles.
This device is intended for adult and pediatric patients.
The BD Quincke Spinal Needle, BD Whitacre Spinal Needle are available in various gauges and needle lengths. The needle consists of a hollow needle (cannula) bonded to a clear hub at one end and a specific needle-point type (Quincke or Whitacre) at the other end. The stylet has a handle, which is color-coded and correlates to the gauge size.
The BD Spinal Needle Introducer consists of a needle, needle hub and needle shield and is available in various gauges. The needle consists of a hollow needle (cannula) bonded to a translucent colored hub (per gauge) at one end and a specific needle-point type at the other end. The introducer needle is optional aid through which a spinal needle can be inserted.
The BD Quincke Spinal Needle, BD Whitacre Spinal Needle and BD Spinal Needle Introducer devices are single use, sterile needles which, incorporate the ISO 594-1 and ISO 594-2 compliant connector. The needles are also available in bulk, non-sterile configurations (to be sterilized prior to use).
The document is a 510(k) summary for the BD Quincke Spinal Needle, BD Whitacre Spinal Needle, and BD Spinal Introducer Needle. It describes the acceptance criteria and the studies performed to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Testing (All per ISO 594 unless specified) | |
| Fluid leakage by Pressure Decay | Met ISO 594 requirements |
| Subatmospheric pressure air leakage | Met ISO 594 requirements |
| Stress cracking | Met ISO 594 requirements |
| Resistance to separation from axial load | Met ISO 594 requirements |
| Resistance to separation from unscrewing | Met ISO 594 requirements |
| Resistance to overriding | Met ISO 594 requirements |
| Stylet Pull Force (per BD internal requirements) | |
| - Quincke Needle 18G | ≥ 8 lbf |
| - Quincke Needle 20G | ≥ 5 lbf |
| - Quincke Needle 22G | ≥ 5 lbf |
| - Quincke Needle 23G | ≥ 5 lbf |
| - Quincke Needle 25G | ≥ 3.5 lbf |
| - Quincke Needle 26G | ≥ 3.5 lbf |
| - Quincke Needle 27G | ≥ 3.5 lbf |
| - Whitacre Needle 22G | ≥ 5 lbf |
| - Whitacre Needle 24G | ≥ 5 lbf |
| - Whitacre Needle 25G | ≥ 5 lbf |
| - Whitacre Needle 27G | ≥ 5 lbf |
| Handle/Hub Separation Force (per BD internal requirements) | Handle must not disengage when held upside down (Met requirements) |
| Needle Shield/Hub Separation Force (per BD internal requirements) | Needle shield must not disengage from hub when held upside down (Met requirements) |
| Cannula Pull Force (Bond between hub and needle) | Met ISO 7864:2016 requirements |
| Biocompatibility Testing (All per ISO 10993-1:2018 unless specified) | |
| Cytotoxicity | Non-cytotoxic (Per ISO 10993-5:2009) |
| Sensitization | Non-sensitizer (Per ISO 10993-10:2010) |
| Intracutaneous Reactivity | Non-irritant (Per ISO 10993-10:2010) |
| Acute Systemic Toxicity | Non-toxic (Per ISO 10993-11:2017) |
| Material-Mediated Pyrogenicity | Non-pyrogenic (Per ISO 10993-11:2017 and USP) |
| Chemical Characterization | Acceptable extractables/leachables profile (Per ISO 10993-18:2005) |
| Additional Testing | |
| Hemolysis | Non-hemolytic (Per ISO 10993-4:2017) |
| LAL Endotoxin | 2.15 EU/device (Per USP, met limits) |
| Particulate Matter | Met limits (Per USP ) |
| Neurotoxicity Assessment | No signs of systemic toxicity or neurological impairment from exposure of leachable compounds from the test article. |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each of the functional and biocompatibility tests. It indicates that the tests were performed according to specified ISO standards and internal requirements. Data provenance is not specified beyond the fact that these are non-clinical/design verification tests performed by BD. There is no indication of country of origin for any data or whether it is retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The tests performed are engineering and biocompatibility evaluations of physical device properties, not assessments requiring expert interpretation of clinical data in the same way an AI/ML device would.
4. Adjudication Method
Not applicable. This is not a study requiring adjudication of interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a 510(k) submission for conventional medical devices (needles), not an AI-assisted device.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is not an algorithm-based device.
7. Type of Ground Truth Used
The "ground truth" for the performance criteria in this submission is based on established engineering standards (e.g., ISO 594, ISO 7864, ISO 10993, USP) and internal company requirements for device functionality and safety. The performance is measured against these objective, predefined criteria rather than a subjective "ground truth" established by experts or clinical outcomes in the context of diagnostic accuracy.
8. Sample Size for Training Set
Not applicable. This is not an AI/ML device, therefore, there is no training set.
9. How Ground Truth for Training Set Was Established
Not applicable. There is no training set.
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(287 days)
RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit
Spinal Needles
Spinal and Epidural needles are to be used to inject local anesthetics into a patient to provide regional anesthesia.
RELI® NRFit® Spinal Needles, RELI® NRFit® Epidural Needles, Phoenix NRFit® Spinal Needles, and Phoenix NRFit® Epidural Needles are intended to be used for injection of local anesthetics into a patient to provide regional anesthesia. The Spinal and Epidural needles are supplied in bulk nonsterile, or sterile by ethylene oxide gas in peel open packages and are intended for one-time use.
The RELI® NRFit® Spinal Needles, RELI® NRFit® Epidural Needles, Phoenix NRFit® Spinal Needles, and Phoenix NRFit® Epidural Needles feature an ISO 80369-6 compliant connector that is about 20% smaller than the predicate device. The ISO 80369-6 hub design reduces the risk of cross connection when used with luer connectors developed under the same series of standards.
RELI® NRFit® Spinal Needles and Phoenix NRFit® Spinal Needles are composed of a stainless-steel cannula and stylet, a hub, and plunger. The spinal needle is supplied with either the Quincke Point (K-3 Point) or the Pencil Point tip configuration.
Quincke point spinal needles feature fitted, close tolerance stylet and cannula bevel to minimize coring and trauma; large clear hubs for enhanced tactile feel and visualization of CSF; color coded stylet hub to easily identify gauge size; some sizes are also available with short bevel. Available in sterile and non-sterile packaging.
Pencil point spinal needles feature an atraumatic point with side-port dispensing to reduce loss of CSF; large clear hubs for enhanced tactile feel and visualization of CSF; color coded stylet hub to easily identify gauge size. Some sizes are available with tapered design to counter bending and minimize flexing during insertion. Available in sterile and non-sterile packaging.
The RELI® NRFit® Epidural Needles and Phoenix NRFit® Epidural Needles are composed of a stainlesssteel cannula, a polycarbonate hub and detachable wing, a stainless-steel stylet and plunger as Tuohy (Huber point) tip configuration in various needle gauge sizes and lengths.
Epidural needles feature large clear hub for enhanced tactile feel; wide metric marking for maximum visibility and accuracy in placement; color coded stylet/hub to identify needle gauge size. Epidural needles are available in sterile and non-sterile packaging.
The provided text is a 510(k) summary for medical devices (spinal and epidural needles) and does not describe the acceptance criteria or a study proving that an AI/ML powered device meets acceptance criteria. The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, indications for use, and non-clinical performance testing (biocompatibility, functional, sterilization).
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from this document as it pertains to a different type of medical device assessment.
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(269 days)
Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal Needles with
The Portex® Lancet Point Spinal Needles with NRFit™ connectors are indicated for the injection of local anesthetics or narcotics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults.
The Portex® Pencil Point Spinal Needles with NRFit™ connectors are indicated for the injection of local anesthetics or narcotics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults.
The PORTEX® Lancet Point Spinal Needle with NRFit™ connectors and PORTEX® Pencil Point Spinal Needles with NRFit™ connectors are indicated for the injection of local anesthetics or narcotics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults.
The NRFit ™ connectors conform to ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The connectors are not compatible with standard luer connectors which is intended to reduce the risk of misconnection that may result in the infusion of medications not intended for neuraxial or regional anesthetic use.
The PORTEX® NRFit™ Spinal Needles are color-coded yellow to indicate medication intended for neuraxial or regional anesthetic delivery.
This Premarket Notification Traditional 510(k) includes various configurations of PORTEX® Lancet Point with NRFit TM connectors and PORTEX® Pencil Point Spinal with NRFit TM connectors.
The provided text details the non-clinical testing performed to demonstrate substantial equivalence for the Portex® Lancet Point Spinal Needles and Portex® Pencil Point Spinal Needles with NRFit™ connectors to their predicate devices. This is a premarket notification (510(k)) to the FDA, which focuses on demonstrating substantial equivalence rather than proving device efficacy from scratch.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for functional performance tests are primarily based on ISO 80369-6: Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications. While specific numerical acceptance criteria are not explicitly detailed in the summary, the document states that "All testing met pre-established specifications," implying adherence to the pass/fail criteria outlined in the referenced ISO standards.
| Category | Evaluation | Test Criteria (Acceptance Criteria) | Reported Device Performance |
|---|---|---|---|
| Functional Performance | Resistance to overriding | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device successfully resisted overriding according to the ISO standard. |
| Resistance to separation from axial load | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device successfully resisted separation from axial load according to the ISO standard. | |
| Resistance to separation from unscrewing | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device successfully resisted separation from unscrewing according to the ISO standard. | |
| Leakage by Pressure Decay | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device met the leakage by pressure decay requirements of the ISO standard. | |
| Subatmospheric Pressure | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device met the subatmospheric pressure requirements of the ISO standard. | |
| Stress Cracking | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device successfully resisted stress cracking according to the ISO standard. | |
| Verifying Non-interconnectable characteristics (physical force) | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device successfully demonstrated non-interconnectable characteristics according to the ISO standard. | |
| Packaging | Package integrity, sterile barrier | ISO 11607, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device met the sterile barrier and packaging integrity requirements of ISO 11607. |
| Sterilization | Sterility | ISO 11135, Sterilization of health care products - Ethylene Oxide - Requirements for development, validation and routine control of a sterilization process for medical devices. | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device met the sterility requirements of ISO 11135. |
| Residuals | ISO 10993-7, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device met the ethylene oxide sterilization residuals requirements of ISO 10993-7. | |
| Biocompatibility | Intracutaneous Reactivity | ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable intracutaneous reactivity as per ISO 10993-10. |
| Systemic Toxicity | ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable systemic toxicity as per ISO 10993-11. | |
| Sensitization | ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable sensitization as per ISO 10993-10. | |
| Cytotoxicity | ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable cytotoxicity as per ISO 10993-5. | |
| Genotoxicity, carcinogenicity and reproductive toxicity | ISO 10993-3, Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable genotoxicity, carcinogenicity, and reproductive toxicity as per ISO 10993-3. | |
| Leachable substances | ISO 10993-17, Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable leachable substances as per ISO 10993-17. | |
| Chemical characterization of materials | ISO 10993-18, Biological evaluation of medical devices - Part 18: Chemical characterization of materials | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable chemical characterization as per ISO 10993-18. | |
| Bacterial endotoxins | ANSI/AAMI ST72, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable bacterial endotoxins levels as per ANSI/AAMI ST72. | |
| Particulate matter | USP 788, Particulate Matter in Injections | "All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable particulate matter levels as per USP 788. |
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a series of non-clinical performance tests as summarized in "Table 2: Summary of Non-Clinical Testing" and described in Section 7 of the document. These tests evaluated the functional performance of the NRFit™ connectors, packaging integrity, sterilization effectiveness, and biocompatibility of the materials.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each of the non-clinical tests. It states that "various configurations" of the spinal needles were included. The data provenance is also not explicitly stated in terms of country of origin, nor whether it was retrospective or prospective. Given it's non-clinical testing (bench testing, lab tests), these details are typically less relevant than for clinical trials. The tests were performed in a controlled laboratory environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of submission. The ground truth for non-clinical performance and biocompatibility tests is established by adherence to recognized international and national standards (e.g., ISO, ANSI/AAMI, USP). There are no "experts" in the sense of clinicians establishing a "ground truth" on patient data for this kind of engineering and laboratory testing.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation relies on objective measurements against pre-defined engineering and biological standards, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for imaging devices or diagnostic tools where human readers interpret results, and the AI's impact on their performance is being evaluated. This submission concerns spinal needles, which are physical medical devices, not an AI or diagnostic algorithm, so an MRMC study is not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical medical instrument (spinal needle), not a software algorithm or an AI.
7. The Type of Ground Truth Used
For this submission, the "ground truth" is defined by established international and national standards (e.g., ISO 80369-6, ISO 11607, ISO 11135, ISO 10993 series, ANSI/AAMI ST72, USP 788). The device's performance is compared against the requirements and specifications outlined in these standards.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of this device and its non-clinical testing. Training sets are used in machine learning and AI development, which is not relevant here.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
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(296 days)
Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.)
PORTEX® products and components with the NRFit™ Connector are intended for the injection or infusion of regional anesthetics or narcotics.
The PORTEX® LOR Syringe with NRFit™ Connector is intended for use with NRFit™ compatible components to verify needle tip placement in the epidural space by the Loss of Resistance technique using air or saline. The NRFit™ connector is designed to be used with regional anesthesia systems only.
The PORTEX® EpiFuse Catheter with NRFit™ Connector is intended for use with the catheter and compatible components for the injection or infusion of regional anesthetics or narcotics. The key is a tool for re-opening the catheter connector.
PORTEX® Epidural Flat Filter with NRFit™ Connector is designed for use when administering injections and/or infusions of regional anesthetics or narcotics to a patient via compatible system components. The NRFit™ Connector is designed to be used with regional anesthesia systems only.
The PORTEX® Filter Needle with NRFit™ Connector and PORTEX® Filter Straw with NRFit™ Connector are intended to draw up medication when using the PORTEX® LOR Syringe.
The PORTEX® Regional Anesthesia Portfolio with NRFit™, consisting of five (5) categories of product including PORTEX® LOR Syringe with NRFit™ Connector, PORTEX® EpiFuse Catheter with NRFit™ Connector, PORTEX® Epidural Flat Filter with NRFit™ Connector and the PORTEX® Filter Straw with NRFit™ Connector.
PORTEX® products and components with NRFit™ connector are intended for the injection or infusion of regional anesthetics or narcotics.
The NRFit ™ connector conform to ISO 80369-6. Small bore connector for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The connectors are not compatible with standard luer connectors which are intended to reduce the risk of misconnection that may result in the infusion of medications not intended for neuraxial or regional anesthetic use.
The PORTEX® Regional Anesthesia Portfolio with NRFit™ connector are color-coded yellow to indicate medication intended for neuraxial or regional anesthetic delivery.
This looks like a 510(k) summary for a medical device modification, specifically for the PORTEX® LOR Syringe with NRFit™ Connector, PORTEX® EpiFuse Catheter with NRFit™ Connector, PORTEX® Epidural Flat Filter with NRFit™ Connector, PORTEX® Filter Needle with NRFit™ Connector, and PORTEX® Filter Straw with NRFit™ Connector.
This document does not describe a study involving AI/ML performance, human readers, or expert adjudication for image analysis. Instead, it focuses on the non-clinical performance testing of a new medical device connector (NRFit™) to demonstrate its substantial equivalence to a predicate device. The acceptance criteria and the "study" that proves the device meets them are based on these non-clinical, bench-top tests, primarily conforming to existing ISO standards.
Therefore, for aspects related to AI/ML, human readers, expert ground truth, and training data, the response will state that this information is not applicable to this type of device submission.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a set of medical connectors, and the "performance" here relates to physical and biological safety and efficacy as defined by recognized standards.
| Category | Evaluation | Test Criteria (Acceptance Criteria) | Reported Device Performance |
|---|---|---|---|
| Functional Performance (NRFit™ Connector) | Resistance to overriding | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | Met pre-established specifications and performed as intended |
| Resistance to separation from axial load | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | Met pre-established specifications and performed as intended | |
| Resistance to separation from unscrewing | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | Met pre-established specifications and performed as intended | |
| Leakage by Pressure Decay | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | Met pre-established specifications and performed as intended | |
| Subatmospheric Pressure | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | Met pre-established specifications and performed as intended | |
| Stress Cracking | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | Met pre-established specifications and performed as intended | |
| Verifying Non-interconnectable characteristics (physical force) | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | Met pre-established specifications and performed as intended | |
| Packaging | Package integrity, sterile barrier | ISO 11607, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems | Met pre-established specifications and performed as intended |
| Sterilization | Sterility | ISO 11135, Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices. | Met pre-established specifications and performed as intended |
| Biocompatibility | Residuals (Ethylene Oxide) | ISO 10993-7, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals | Met pre-established specifications and performed as intended |
| Intracutaneous Reactivity | ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Met pre-established specifications and performed as intended | |
| Systemic Toxicity | ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Met pre-established specifications and performed as intended | |
| Sensitization | ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Met pre-established specifications and performed as intended | |
| Cytotoxicity | ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Met pre-established specifications and performed as intended | |
| Genotoxicity, carcinogenicity and reproductive toxicity | ISO 10993-3, Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity | Met pre-established specifications and performed as intended | |
| Leachable substances | ISO 10993-17, Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances | Met pre-established specifications and performed as intended | |
| Chemical characterization of materials | ISO 10993-18, Biological evaluation of medical devices - Part 18: Chemical characterization of materials | Met pre-established specifications and performed as intended | |
| Bacterial endotoxins | ANSI/AAMI ST72, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing | Met pre-established specifications and performed as intended | |
| Particulate matter | USP 788, Particulate Matter in Injections | Met pre-established specifications and performed as intended |
2. Sample Size Used for the Test Set and the Data Provenance
This document does not specify a "test set" in the context of AI/ML or image data. The testing described is non-clinical (bench testing) for device components. The sample size for each specific non-clinical test (e.g., number of connectors tested for axial load) is not explicitly provided in this summary but would be detailed in the full test reports. Data provenance is not applicable here as it refers to physical and biological testing of manufactured products, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a submission for physical medical devices and their connectors, not an AI/ML diagnostic or prognostic device that relies on expert interpretation of data for ground truth.
4. Adjudication Method for the Test Set
Not applicable. The "test set" here refers to physical product testing against international standards, not a diagnostic or classification task requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is not an AI-assisted diagnostic or imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by objective measurements and assessments against recognized international and national standards (e.g., ISO 80369-6, ISO 11607, ISO 11135, ISO 10993 series, ANSI/AAMI ST72, USP 788) for functional performance, sterility, packaging, and biocompatibility.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML algorithm.
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(114 days)
PENCAN SPINAL NEEDLE
The Pencan spinal needles with or without introducer are intended for the injection of local anesthetics into the subarachnoid space to provide spinal anesthesia for pain management or to facilitate CSF sample collection for diagnostic purposes (lumbar puncture). The needles are intended for use in any target population with consideration given to the anatomy of the patient.
The Spinocan spinal needles with or without introducer are intended for the injection of local anesthetics into the subarachnoid space to provide spinal anesthesia for pain management or to facilitate CSF sample collection for diagnostic purposes (lumbar puncture). The needles are intended for use in any target population with consideration given to the anatomy of the patient.
The B. Braun Pencan Spinal Needle consists of a polycarbonate hub bonded to a stainless steel cannula with pencil-point tip. The hub of the Pencan spinal needle incorporates a viewing window for visualization of cerebrospinal fluid. The needles are provided with a stylet with color-coded hub that corresponds to the needle gauge. The needles will be offered in gauges ranging from 22 Ga. to 27 Ga. Needles that are 24 Ga .- 27 Ga. may be used with an individually packaged 20 Ga. or 22 Ga. introducer needle.
The B. Braun Spinocan Spinal Needle consists of the same polycarbonate hub as the Pencan needles. The hub is bonded to a stainless steel cannula with Quincke bevel. The needles are provided with a stylet with color-coded hub that corresponds to the needle gauge. The needles will be offered in gauges ranging from 18 Ga. to 27 Ga. Needles that are 25 Ga. - 27 Ga. may be used with an individually packaged 20 Ga. or 22 Ga. introducer needle.
Here's an analysis of the provided text regarding the acceptance criteria and study for the B. Braun Medical Inc. Pencan, Spinocan Spinal Needles and Spinal Introducer Needles:
Based on the provided 510(k) summary (K112515), the device in question is a medical needle, not an AI/ML powered device. Therefore, many of the requested criteria related to AI/ML device studies (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this submission.
The acceptance criteria and study focus on demonstrating substantial equivalence to predicate devices through performance testing against established international standards and biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|
| ISO 9626:1991/Amd. 1:2001(E): "Stainless steel needle tubing for the manufacture of medical devices." | "Results of performance testing indicate that the needles meet applicable sections of the standards referenced and are safe and effective for their intended use." (Implies compliance with the specified ISO standard for needle tubing.) |
| ISO 7864:1993(E): "Sterile hypodermic needles for single use." | "Results of performance testing indicate that the needles meet applicable sections of the standards referenced and are safe and effective for their intended use." (Implies compliance with the specified ISO standard for sterile hypodermic needles.) |
| ISO 594-1:1986: "Conical Fittings with a 6 % Luer taper for syringes, needles and certain other medical equipment - Part1: General Requirements." | "Results of performance testing indicate that the needles meet applicable sections of the standards referenced and are safe and effective for their intended use." (Implies compliance with the specified ISO standard for Luer taper fittings, confirming proper connection with other medical equipment.) |
| ISO 594-2:1998: "Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 2: Lock fittings." | "Results of performance testing indicate that the needles meet applicable sections of the standards referenced and are safe and effective for their intended use." (Implies compliance with the specified ISO standard for Luer lock fittings, ensuring secure connections.) |
| ISO 10993-1:2009: "Biological evaluation of medical devices - Part I: Evaluation and testing within a risk management process" (Biocompatibility) | "Biocompatibility testing... demonstrates that the materials used in the construction of the proposed needles are safe for their intended use." (Confirms the materials are biologically suitable for patient contact.) |
| Substantial Equivalence to Predicate Devices | The proposed Pencan and Spinocan needles are deemed "similar" to predicate devices (K932569, K820047, K011122) in intended use, needle cannula, tip design, and dimensions, with primary differences being hub geometry, non-solution contacting materials, and additional gauges/lengths. Compliance with performance standards further supports equivalence. |
2. Sample Size Used for the Test Set and the Data Provenance
This is not an AI/ML device study. The "testing" refers to physical and material performance evaluations against established standards, not a clinical trial with patient data. Therefore, concepts like "test set" or "data provenance" in the context of clinical data are not applicable here. The data provenance would be the internal testing laboratories of B. Braun Medical Inc. or contracted testing facilities that conducted the performance and biocompatibility tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable for this type of medical device submission. Ground truth for physical device performance is established by objective measurements against engineering and material science standards (e.g., tensile strength, flow rate, biocompatibility assays), not expert clinical consensus.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or clinical outcomes where there might be disagreement. For a physical device demonstrating compliance with standards, the results are objectively measured.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device and therefore no MRMC study involving human readers with AI assistance was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. Its performance is inherent to its physical design and materials.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by the international standards themselves (ISO 9626, ISO 7864, ISO 594-1, ISO 594-2, ISO 10993-1). The device must meet the specified test methods and criteria outlined in these standards. For biocompatibility, the chemical and biological properties of the materials, as tested according to ISO 10993 guidelines, serve as the ground truth.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device and does not involve a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML device and does not involve a training set.
In summary, for K112515, the "study" demonstrating the device meets acceptance criteria consists of:
- Performance testing against established international standards (ISO).
- Biocompatibility testing in accordance with ISO 10993-1.
- Comparison to predicate devices to demonstrate substantial equivalence based on similar design, materials, and intended use, and successful performance against the aforementioned standards.
The B. Braun Pencan and Spinocan Spinal Needles and Spinal Introducer Needles are traditional medical devices, and their regulatory pathway focuses on demonstrating safety and effectiveness through compliance with recognized standards and substantial equivalence to legally marketed predicate devices, rather than through AI/ML-specific validation studies.
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(15 days)
LCCS INSULATED SPINAL NEEDLE (RF CANNULA)
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(144 days)
MEDLINE EPIDURAL AND SPINAL NEEDLES
This anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.
Not Found
This document is a 510(k) premarket notification approval letter for the Medline Epidural and Spinal Needles. It does not present any clinical study data or acceptance criteria for device performance.
Therefore, I cannot provide the requested information, such as:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or training sets.
- Data provenance or details about experts.
- Adjudication methods.
- MRMC study information.
- Standalone performance.
- Types of ground truth.
This letter solely indicates that the FDA has reviewed the device and determined it to be substantially equivalent to legally marketed predicate devices, allowing it to be marketed subject to general controls. It does not contain the detailed study results and performance metrics typically found in a clinical study report or a summary of safety and effectiveness data.
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(115 days)
BD SPINAL NEEDLE 27G
An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.
The BD Spinal needle consists of a non-lubricated stainless steel cannula attached to the needle hub using an insert molding process. When appropriate for the procedure, this needle includes a stylet. This stylet consists of nonlubricated stainless steel. The stainless steel stylet is attached to the stylet handle using an insert molding process. The needle assembly is protected with a polypropylene shield. The Spinal needle is packaged appropriately for either sterile or non-sterile, single use, purposes.
The provided document is a 510(k) summary for a medical device (BD Spinal Needle) seeking substantial equivalence to a predicate device. It is a regulatory submission, not a study report that details acceptance criteria and performance data for a new device's efficacy or safety. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies is not present in this document.
The document discusses the substantial equivalence of the BD Spinal Needle to existing predicate devices based on identical technological characteristics and intended use. This type of submission relies on the established safety and effectiveness of the predicate, rather than conducting new clinical performance studies for the new device itself.
Here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | The BD Spinal Needle and the predicate device have the same identical technological characteristics and perform equivalently. |
| Based on comparison of device features, materials, intended use, and performance, the BD Spinal Needle has shown to be substantially equivalent to the commercially available predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not applicable and not provided. This submission relies on demonstrating substantial equivalence to a predicate device, not on a new performance study with a test set of data.
- Data provenance: Not applicable. No new data from a test set is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable and not provided. No ground truth for a test set was established as part of this submission. The regulatory review process involves FDA experts evaluating the submission for substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable and not provided. No test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC or AI-related study was done. This device is a physical medical instrument (spinal needle), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" in this context refers to the established safety and effectiveness of the predicate device, which is assumed by the FDA for substantial equivalence evaluations. No new ground truth needed to be established for the submitted device's performance.
8. The sample size for the training set:
- Not applicable and not provided. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable and not provided. No training set was used.
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(56 days)
BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237
An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.
The BD Spinal needle consists of a non-lubricated stainless steel cannula attached to the needle hub using an epoxy adhesive. When appropriate for the procedure, this needle includes a stylet. This stylet consists of non-lubricated stainless steel. The stainless steel stylet is attached to the stylet handle using an epoxy adhesive. The needle assembly is protected with a polypropylene shield. The Spinal needle is packaged appropriately for either sterile or nonsterile, single use, purposes.
This document is a 510(k) summary for the BD Spinal Needle. It asserts substantial equivalence to existing predicate devices rather than presenting a study demonstrating it meets specific acceptance criteria based on novel performance.
Therefore, many of the requested categories are not applicable or cannot be extracted from the provided text, as this type of submission focuses on equivalence to already approved devices rather than a de novo performance study against defined criteria.
Here's a breakdown of the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. This 510(k) submission does not present specific acceptance criteria or performance data for the BD Spinal Needle in the typical sense of a de novo device study. Instead, it claims "identical technological characteristics and perform equivalently" to predicate devices. There are no quantitative measures or thresholds mentioned that the device needed to meet.
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable. No specific test set or data provenance details are provided in this 510(k) summary. The submission relies on establishing substantial equivalence to predicate devices based on design and intended use, not on a new comparative performance study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not Applicable. No test set or ground truth establishment process is described.
4. Adjudication Method for the Test Set
Not Applicable. No test set or adjudication process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. A MRMC comparative effectiveness study was not done, as this submission is for a spinal needle, which is a physical medical device, not a diagnostic imaging or AI system typically subject to MRMC studies.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not Applicable. This device is a physical spinal needle; there is no algorithm or AI component to evaluate.
7. The Type of Ground Truth Used
Not Applicable. No ground truth establishment is described for performance evaluation. The "ground truth" for this submission would be the established safety and effectiveness of the predicate devices.
8. The Sample Size for the Training Set
Not Applicable. This is a physical medical device, not a machine learning model, so there is no training set in the context of AI.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. There is no training set mentioned or implied.
Summary of Device's Argument for Meeting "Acceptance Criteria" (Substantial Equivalence):
The "acceptance criteria" for this 510(k) submission is to demonstrate substantial equivalence to legally marketed predicate devices.
- Predicate Devices: BD Spinal Needle, BD Precisionglide Needle, BD Hypoint Needle (all manufactured by Becton, Dickinson and Company).
- Method of Proof: Comparison of device features, materials, intended use, and existing device performance.
- Conclusion: The sponsor states that "The BD Spinal Needle and the predicate device have the same identical technological characteristics and perform equivalently." This assertion is the primary "proof" for this type of submission.
The FDA's letter confirms that they reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This regulatory determination signifies that the device has met the "acceptance criteria" for marketing under a 510(k) pathway, which is substantial equivalence.
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