(236 days)
Disposable Needle Guides and Grids are used to assist and aid physicians in performing an endocavity diagnosis ultrasound needle guided procedure using guided intervention fixed guiding for the precise insertion of linear instruments, such as needle Guides and Grids are designed to aid adult patient population, in need of a biopsy of an internal organ, or internal delivery or removal of fluid within the body cavity, via the use of a needle, during an ultrasound procedure by retaining the needle tip and barrel within the ultrasound beam.
Advance Medical Designs' disposable needle guides & grids devices used to direct needles or instruments along a fixed path to a target location with an ultrasound traducer. They are provided in a variety of sizes to fit different equipment and situations. The Needle Guides and Grids are packaged separately, or within kits, provided sterile, and are labelled as single use only. Each disposable needle guide & grid contains a bracket and needle adapter. Each kit includes a disposable needle guide, a 20ml packet of ASonic® sterile gel, two latex free elastic bands, and a transducer cover (Latex or Latex-Free). The needle guides are non-invasive and have contact with only intact skin.
The provided document is a 510(k) Pre-market Notification for a medical device called "Disposable Needle Guides and Grids" by Advance Medical Designs, Inc. This document details the device's characteristics, indications for use, comparison to predicate and reference devices, and testing performed to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document implicitly defines acceptance criteria through the various tests and their corresponding pass/fail conditions. While not presented in a single table, the summary of non-clinical and bench testing demonstrates the device's performance against these criteria.
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meets ISO 10993-1 and ASCA-Pilot Biocompatibility Guidance requirements for limited contact duration (surface devices of breached/compromised surface, external communicating tissue, indirect blood path). Specific tests include: Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Material-Mediated Pyrogenicity (ISO 10993-11 and USP 151), Direct/Indirect Hemolysis/Hemocompatibility (ISO 10993-4 and ASTM F756). | Sufficient evidence provided to validate AMD's claim that subject materials/device are non-toxic, non-sensitizing, non-irritating, non-hemolytic, and non-pyrogenic. (Section 10) |
| Mechanical Performance | Cover Breach and Probe Damage Testing: No damage to cover or probe due to material attachment of needle guide over a cover. | Water leak testing performed during Design Input, Design Output, and Design Validation stages demonstrated material attachment of needle guide over a cover did not cause damage to cover or probe. (Section 11) |
| Retention and Movement Testing: Minimum force of 8N to dislodge the guide. | Force testing on needle guide attachment ensured a minimum force of 8N would not cause the guide to dislodge. (Section 11) | |
| Needle Drag Testing: Force less than 1.5N when passing a cannula through the needle guide, with no binding. | Force testing performed by passing a cannula through the needle guide ensured binding would not occur and force was less than a 1.5N threshold. (Section 11) | |
| Needle Path Verification Testing: Needle path falls within specified design tolerances. | Needle guides tested on test fixtures to ensure needle path falls within the design tolerances specified for the design. (Section 11) | |
| Usability | Simulated Usability Testing: Design conforms to user needs and intended use. | Simulated use evaluations performed by customers ensured the design of the needle guide conforms to the user needs and intended use, as well as imaging testing conducted through laboratory evaluations. (Section 11) |
| Sterilization | Ethylene Oxide sterilization with SAL 10⁻⁶. | The manufacturing process includes 100% EtO sterilization with SAL 10⁻⁶, which was evaluated for biological effects. (Section 10) |
| Shelf-Life | 3 Years. | Device has a 3-year shelf-life, matching the predicate device. (Section 9) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample sizes for the specific tests, nor does it detail the provenance of the data (e.g., country of origin, retrospective or prospective nature of the test subjects if applicable). The tests mentioned are predominantly non-clinical bench tests and simulated use evaluations, implying laboratory settings rather than patient data.
- Bench Testing: The description of tests like "Water leak testing," "Force testing," and "Needle path verification testing" suggests that these were conducted on a sample of the manufactured devices.
- Simulated Usability Testing: "Simulated use evaluations were performed by customers." The number of customers involved or how the evaluation was conducted (e.g., number of sessions, different scenarios) is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
The concept of "ground truth" and "experts" as typically understood in studies involving diagnostic accuracy (e.g., image interpretation by radiologists) is not directly applicable here. This device, "Disposable Needle Guides and Grids," is a mechanical accessory; its primary function is to physically guide a needle.
- For the mechanical performance tests, the "ground truth" is established by engineering specifications and physical measurements (e.g., 8N force threshold, 1.5N drag threshold, design tolerances for needle path). These are typically assessed by engineers or quality control personnel.
- For simulated usability testing, "customers" performed evaluations. Their qualifications are not mentioned, but it's implied they are intended users (physicians or clinicians) who would assess the device's ease of use and how well it meets their needs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Adjudication methods like "2+1" or "3+1" are relevant for studies where expert disagreement on diagnostic interpretation needs to be resolved. Since this device is a mechanical guide and the testing focuses on physical and biological performance, such adjudication methods are not applicable. The bench test results would likely be determined by meeting predefined engineering specifications.
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:
An MRMC comparative effectiveness study was not done. The device is a physical accessory, not an AI-powered diagnostic tool, so the concept of human readers improving with AI assistance does not apply. The submission explicitly states: "Clinical tests were not required to demonstrate substantial equivalence." (Section 12).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is also not applicable. The device is a physical, non-electronic accessory. There is no algorithm or standalone performance in the sense of an AI or software product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As discussed in point 3, the "ground truth" for this device's evaluation is primarily based on:
- Engineering Specifications/Physical Measurements: For mechanical performance tests (retention, drag, needle path accuracy).
- Biocompatibility Standards: ISO 10993 series and ASCA-Pilot Biocompatibility Guidance for material safety.
- User Feedback: "Simulated use evaluations were performed by customers" to ensure conformity to user needs.
There is no mention of expert consensus, pathology, or outcomes data, as these types of ground truth are usually associated with diagnostic or therapeutic efficacy studies involving patient data, which was not the focus of this 510(k) submission.
8. The sample size for the training set:
There is no mention of a "training set" as this device is not a machine learning or AI-based product. The testing performed is to validate the physical and biological characteristics of the manufactured device.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
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August 2, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Advance Medical Designs, Inc. % David Mackie QA/RA Manager 1241 Atlanta Industrial Drive MARIETTA GA 30066
Re: K223689
Trade/Device Name: Disposable Needle Guides and Grids Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: Class II Product Code: ITX Dated: June 21, 2023 Received: July 3, 2023
Dear David Mackie:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223689
Device Name Disposable Needle Guides and Grids
Indications for Use (Describe)
"Disposable Needle Guides and Grids are used to assist and aid physicians in performing an endocavity diagnosis ultrasound needle guided procedure using guided intervention fixed guiding for the precise insertion of linear instruments, such as needle Guides and Grids are designed to aid adult patient population, in need of a biopsy of an internal organ, or internal delivery or removal of fluid within the body cavity, via the use of a needle, during an ultrasound procedure by retaining the needle tip and barrel within the ultrasound beam."
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary Advance Medical Designs, Inc. Common Name: Needle Guides & Grids This summary of Traditional 510(k) Submission of safety and effectiveness of information is being prepared in accordance with the requirements of 21 CFR 807.92. April 19, 2023 Assigned 510(k) NUMBER: K223689.
1. Submitter's Identifications:
| 510(k) owner's name: | Advance Medical Designs, Inc. |
|---|---|
| Owner/Operator #: | 1037885 |
| Establishment: | Advance Medical Designs, Inc. |
| Address: | 1241 Atlanta Industrial Drive |
| Marietta, GA 30066 USA | |
| Phone Number: | (770) 422-3125 |
| Facility Registration #: | 1037885 |
| Contact person: | David Mackie: QA/RA Manager at Advance Medical Designs, Inc. |
|---|---|
| Phone Number: | (770) 422-3125 ext. 244 |
| e-mail: | mackied@advmeddes.com |
2. Date 510(k) Summary Prepared: April 19, 2023
3. Name of Subject Device and Classification Information:
| Trade name: | Disposable Needle Guides and Grids |
|---|---|
| Regulation Number: | 21 CFR 892.1570 |
| 510(k) Number: | K223689 |
| Common Name: | Needle Guides & Grids |
| Classified Name: | Diagnostic ultrasonic transducer accessories |
| Regulatory Class: | Class II |
| Product Code: | ITX |
4. Information for the Predicate Device:
- A) PRIMARY PREDICATE DEVICE:
| Trade Name/Device Name: | Disposable Endocavity Needle / Biopsy Guide |
|---|---|
| Manufacturer: | CIVCO Medical Instruments Co., Inc. |
| 510(k) Number: | K972514 |
| Regulation Number: | 21. CFR 892.1570 |
| Classification Name: | Diagnostic ultrasonic transducer accessories |
| Regulatory Class: | Class II |
| Product Code: | ITX |
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5. Information for Reference Devices:
| A) REFERENCE DEVICE: | |
|---|---|
| Trade Name/Device Name: | Disposable Guides KDNG00 |
| Manufacturer: | KOELIS |
| 510(k) Number: | K180970 |
| Regulation Number: | 21. CFR 892.1570 |
| Classification Name: | Diagnostic ultrasonic transducer accessories |
| Regulatory Class: | Class II |
| Product Code: | ITX |
| B) REFERENCE DEVICE: | |
| Trade Name/Device Name: | VitroPRO / Disposable Endocavity Needle Guide |
| Manufacturer: | CIVCO Medical Instruments Co., Inc. |
| 510(k) Number: | K222052 |
| Regulation Number: | 21. CFR 892.1570 |
| Classification Name: | Diagnostic ultrasonic transducer accessories |
| Regulatory Class: | Class II |
| Product Code: | ITX |
| C) REFERENCE DEVICE: | |
| Trade Name/Device Name: | Reusable Guide |
| Manufacturer: | KOELIS |
| 510(k) Number: | K141334 |
| Regulation Number: | 21. CFR 892.1570 |
| Classification Name: | Diagnostic ultrasonic transducer accessories |
| Regulatory Class: | Class II |
| Product Code: | ITX |
Description of Subject Device:
Advance Medical Designs' disposable needle guides & grids devices used to direct needles or instruments along a fixed path to a target location with an ultrasound traducer. They are provided in a variety of sizes to fit different equipment and situations. The Needle Guides and Grids are packaged separately, or within kits, provided sterile, and are labelled as single use only. Each disposable needle guide & grid contains a bracket and needle adapter. Each kit includes a disposable needle guide, a 20ml packet of ASonic® sterile gel, two latex free elastic bands, and a transducer cover (Latex or Latex-Free). The needle guides are non-invasive and have contact with only intact skin.
Needle Guide/Grid: ABS Stainless Steel Polypropylene
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Rolled Latex-Free Probe Cover K011265: Polyisoprene
Rolled Latex Probe Cover K011265: Latex Rubber
20ml. Sterile Ultrasound Gel 510(k)# K163050:
Device Characteristics of Advance Medical Designs, Inc. Needle Guides and Grids:
- Hypoallergenic, non-irritating
- No toxic effects
- Produced with completely harmless material.
- Does not damage the probe.
- Non-Invasive
- Contact with only intact skin, or with breached surfaces with duration <60 minutes
- Single Use
- Sterile (EtO Sterilization)
Device Identification-Model Numbers and Components:
The differences among the model numbers are limited to the convenience kits they are packaged into, the probe/ transducer/ ultrasound system they are compatible with, and the size specific dimensions indicating which Needle Gauge is appropriate for use. All Product Labels include the name of the specific compatible ultrasound systems that the Needle Guides and Grids are designed to fit. All Product Models are manufactured with the same ABS Polypropylene and injection molded. All accessories and kits are composed of the same accessories:
-
Advance Medical Designs (AMD) 20ml. Sterile Ultrasound Gel 510(k)# K163050:
-
Rolled Latex or Latex Free Probe/Transducer Cover 510(k)# K011265:
Indications for Use:
"AMD's (Advance Medical Designs) Disposable Needle Guides and Grids are used to assist and aid physicians in performing an endocavity diagnosis ultrasound needle guided procedure using guided intervention by providing fixed guiding for the precise insertion of linear instruments, such as needles. The Needle Guides and Grids are designed to aid adult patient population, in need of a biopsy of an internal organ, or internal delivery or removal of fluid within the body cavity, via the use of a needle, during an ultrasound procedure by retaining the needle tip and barrel within the ultrasound beam."
Intended Use:
The Subject Device provides fixed guiding of the precise insertion of linear instruments, such as needles through mechanical means with the use of diagnostic ultrasound equipment. The Needle Guide and Grid is attached over the transducer/ probe/ scanning instruments. The device provides a fixed path for the imaging guidelines for visualizing guided instrument procedures. Advance Medical
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Designs (AMD) Needle Guides and Grids are furnished sterile; single use patient/ procedure, and disposable. The single use, disposable feature helps prevent transfer of microorganisms, body fluid, and particulate material to the patient and healthcare worker during reuse of the transducer. The Needle Guides and Grids are intended to clinicians and assistant clinical and hospital settings, to guide linear instruments during any ultrasound procedure that require the precision use of a needle.
Comparison to Legally Marketed Device (Predicate and Reference Devices):
Subject, Predicate Device and Reference Devices' indications for use place AMD's Needle Guides and Grids and CIVCO (510k# K970514) /KOELIS (510k# K180970) Ultrasound Needle Guides in device body contact categories as follows:
- a) Surface devices, intact skin / mucosal membranes/ breached surfaces, limited contact duration (<24 hours)
- b) External communicating devices, blood path indirect, tissue communicating limited contact duration (<24 hours)
Subject and Predicate Device have a similar Intended Use and Subject, Predicate device, and Reference devices (K180970, K222052) provide mechanical means for performing needle/ instrument guided procedures with the use of diagnostic ultrasound transducers. These devices provide the same fixed path for the needle or instrument that when coupled by the ultrasound system software corresponds to the on-screen imaging guidelines for visualizing guided instrument procedures.
Predicate device, Reference Devices, and Subject device are furnished sterile; and the entire guide is single use patient/ procedure, disposable. The single use, disposable feature helps prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during the reuse of the transducer. CIVCO Needle guide kits also provide ultrasound packets and covers which are similar to the subject device kits.
Reference Device (K141334) utilizes a reusable guide bracket (after cleaning/ sterilization by user) and a sterile, single use, disposable cannula.
| Company | AdvanceMedicalDesigns(SUBJECTDEVICE) | CIVCO(PREDICATEDEVICE) | KOELIS(REFERENCEDEVICE) | CIVCO(REFERENCEDEVICE) | KOELIS(REFERENCEDEVICE) | DeviceCommon/Usual Name | UltrasoundTransducerNeedle/InstrumentGuide | UltrasoundTransducerNeedle/InstrumentGuide | UltrasoundTransducerNeedle/InstrumentGuide | UltrasoundTransducerNeedle/InstrumentGuide | UltrasoundTransducerNeedle/InstrumentGuide | introduce theneedle into thechannel | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Device Name | Disposable NeedleGuides and Grids | DisposableEndocavityUltrasoundNeedle/ BiopsyGuide | Disposable GuidesKDNG00 | VitroPro/DisposableEndocavity NeedleGuide | Reusable GuideKRNG.EL1KRNG.EL4 | DeviceClassificationName | DiagnosticUltrasonicTransducerAccessories | DiagnosticUltrasonicTransducerAccessories | DiagnosticUltrasonicTransducerAccessories | DiagnosticUltrasonicTransducerAccessories | DiagnosticUltrasonicTransducerAccessories | Fixation mechanism of the Guide on the probe: | ||||||
| 510(k)Number | K223689 | K970514 | K180970 | K222052 | K141334 | ClassificationProductCode | ITX | ITX | ITX | ITX, MQE | ITX | A clip to allowthe needleguide stabilityon thetransducer and2 pins forattachment inthe notches forthe probe | A ring locks theneedle guidearound theprobe thanksto a lateralscrew | A clip to allowthe needleguide stabilityon thetransducer and2 pins forattachment inthe notches forthe probe | A ring locks theneedle guidearound theprobe thanksto a lateralscrew | A clip to allowthe needleguide stabilityon thetransducer and2 pins forattachment inthe notches forthe probe | ||
| RegulationNumber | 21 CFR 892.1570 | 21 CFR 892.1570 | 21 CFR 892.1570 | 21 CFR 892.1570/21 CFR 884.6100 | 21 CFR 892.1570 | Indicationsfor Use | Disposable Needle Guides and Grids are used to assist and aid physicians in performingan endocavity diagnosis ultrasound needle guided procedure using guided interventionby providing fixed guiding for the precise insertion of linear instruments, such asneedles. The Needle Guides and Grids are designed to aid adult patient population, in | Materials ofConstruction | Medical GradeThermoplasticABSPolypropylene304 StainlessSteelAll materialshave met therequirementsof ISO 10993-1forbiocompatibility. | ThermoplasticABSPolycarbonate304 StainlessSteelAll materialshave met therequirementsof ISO 10993-1forbiocompatibility. | Medical GradePolycarbonateAll materialshave met therequirementsof ISO 10993-1forbiocompatibility. | ThermoplasticABSPolycarbonate304 StainlessSteelAll materialshave met therequirementsof ISO 10993-1forbiocompatibility. | 304 StainlessSteel3161 StainlessSteel17/4 PHAll materialshave met therequirementsof ISO 10993-1forbiocompatibility. | |||||
| Device class | Class II | Class II | Class II | Class II | Class II | Intended Use | Subject Device, Predicate Device, and References Devices provide fixed guiding of theprecise insertion of linear instruments, such as needles through mechanical means withthe use of diagnostic ultrasound equipment. The Needle Guides and Grids are attachedover the transducer/ probe/ scanning instruments. The device provides a fixed path forthe imaging guidelines for visualizing guided instrument placement procedures.The Needle Guides and Grids are intended to aid clinicians and assistant clinicians, inclinical and hospital settings, to guide linear instruments during any ultrasoundprocedure that requires the precision use of a needle.Subject, Predicate Device and Reference Devices' indications for use and intended useplace AMD's Disposable Needle Guides and Grids and CIVCO (510k# K970514) /KOELIS(510k# K180970) Ultrasound Needle Guides in device body contact categories as follows:a) Surface devices, intact skin / mucosal membranes/ breached surfaces, limitedcontact duration (<24 hours)b) External communicating devices, blood path indirect, tissue communicatinglimited contact duration (<24 hours)Subject and Predicate Device have a similar Intended Use and Subject, Predicate device,and Reference devices (K180970, K222052) provide similar mechanical means forperforming needle/ instrument guided procedures with the use of diagnostic ultrasoundtransducers. | Safety/Biocompatibility | Meets ISO10993-1biocompatibilityyrequirementsfor limitedcontactduration:• surfacedevices ofbreached orcompromisedsurface• Externalcommunicatingindirect bloodpath/tissuecontactDemonstratedto be non-toxic,non-sensitizing,non-irritating, | Meets ISO10993-1biocompatibilityyrequirementsfor limitedcontactduration:• surfacedevices ofbreached orcompromisedsurface• Externalcommunicatingindirect bloodpath/tissuecontactDemonstratedto be non-toxic,non-sensitizing,non-irritating, | Meets ISO10993-1biocompatibilityyrequirementsfor limitedcontactduration:• surfacedevices ofbreached orcompromisedsurface• Externallycommunicatingtissuebone/dentinDemonstratedto be non-toxic,non-sensitizing,non-irritating, | Meets ISO10993-1biocompatibilityyrequirementsfor limitedcontactduration:• surfacedevices ofbreached orcompromisedsurface• Externallycommunicatingtissuebone/dentinDemonstratedto be non-toxic,non-sensitizing,non-irritating, | Meets ISO10993-1biocompatibilityyrequirementsfor limitedcontactduration:• surfacedevices ofbreached orcompromisedsurface• Externallycommunicatingtissuebone/dentinDemonstratedto be non-toxic,non-sensitizing,non-irritating, | |||||
| Design | AdvanceMedicalDesigns NeedleGuide and Gridis a plasticguide designedto be clippedon to anultrasoundprobe, with anentry cone toeasily | Integrates themountingbracket andcannula into asingledisposablecomponentthat attachesexternally, overthe transducerwith a clip-onaction | Plastic guidedesigned to beclipped on anendocavityultrasoundprobe. Anentry cone toeasilyintroduce theneedle into thetube. | Integrates themountingbracket andcannula into asingledisposablecomponentthat attachesexternally, overthe transducerwith a clip-onaction | Inox Guidedesigned to beclipped on anendocavityultrasoundprobe. Anentry cone toeasilyintroduce theneedle into thetube. |
Substantial Equivalence Table:
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| non-hemolytic,andnonpyrogenic | non-hemolytic,andnonpyrogenic | (DOES NOTINCLUDEPYROGEN/HEMO/ ORACUTESYSTEMIC) | (DOES NOTINCLUDEPYROGEN/HEMO/ ORACUTESYSTEMIC) | (DOES NOTINCLUDEPYROGEN/HEMO/ ORACUTESYSTEMIC) | |
|---|---|---|---|---|---|
| Effectiveness | Subject, Predicate, and all Reference Devices are designed for secure and aligned fit to the transducer or probe, while not altering the transducer or probe design integrity or function. Positive Registration features of the design ensure accurate needle path and placement in relation with the transducer. The exterior shapes of the guides are contoured for the patient comfort with no sharp edges. Advance Medical Designs needle guides and grids devices have the same intended use and their technological characteristics do not raise any different questions of safety or effectiveness, as compared to the legally marketed device. Therefore, the Advance Medical Designs needle guides and grids are substantially equivalent to the legally marketed disposable endocavity needle guide marketed by CIVCO (K972514). | ||||
| Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Shelf-Life | 3 Years | 3 Years | 3 Years | 3 Years | 3 Years |
| Accessories | Ultrasound gelpacket andcovers. | Ultrasound gelpacket andcovers. | None provided. | None provided.Intendeduser to providecover andguides whichare IVF usecleared. | None provided. |
| Energy Type | None | None | None | None | None |
| Software | None | None | None | None | None |
Design principles of operation are similar between subject device and predicate device(s):
- Placing the Probe Attachment Bracket on the transducer using locating features
- Securing the needle guide onto the transducer by fastening the Attachment Bracket Lock
- Identifying the angle / position to encourage optimal needle trajectory.
- Releasing the Attachment Bracket Lock to remove the needle guide from the transducer.
Subject Device and Predicate Device(s) integrate the mounting bracket and cannula into a single, disposable component that attaches externally, over the transducer; however predicate device uses a clip-on action and subject device uses an Attachment Bracket Lock. The method of maintaining a secure attachment does not change the intended purpose and the devices maintain fixed positions as intended.
Materials of Construction and Manufacturing:
The Advance Medical Designs' Needle Guides, Grids, and Accessories (Kit) have a nonpharmacological, immunological, or metabolic mode of action and both subject and predicate devices have same Shelf-Life's of 3 years.
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Predicate Device is fabricated from:
-
- Injection molded thermoplastic components, bonded to stainless steel cannula with medical grade adhesive.
- Injection insert-molded thermoplastic with integral stainless-steel cannula 2)
-
- Thermoplastics (ABS and Polycarbonate) and 304 Stainless Steel and packaged in Polyethylene and Tyvek
Subject Device is fabricated from:
-
- Injection molded thermoplastic components, but with a stainless-steel attachment.
-
- Injection insert- molded thermoplastic with integral stainless-steel cannula
-
- Thermoplastics (ABS and Polypropylene) and 304 Stainless Steel and packaged in Polyethylene and Tyvek
Predicate Device and Reference Device (K180970) uses ABS Polycarbonate, and the Subject Device uses ABS Polypropylene.
Chemical Characterization of Polypropylene have been conducted and those studies and results are provided with this application and prove that the materials used to manufacture AMD's Needle Guides and Grids are safe, fully biocompatible, and as effective as Predicate Device and Reference Devices. Materials and manufacturing processing for Predicate Device and Subject Device (including 100 % EtO sterilization w/ SAL 10°) affects to the healthcare worker and patient via intended use/ indications for use contact of this device have been biologically evaluated using biocompatibility tests for cytotoxicity, irritation, sensitization, pyrogenicity, acute system toxicity, and hemocompatibility.
Sufficient evidence is provided to validate AMD's Claim that subject materials/ device to be non-toxic, non-sensitizing, non-irritating, non-hemolytic, and non-pyrogenic.
Modified Technological Characteristics Deviating from Predicate Device(s) Design, Effectiveness, and Safety:
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- Cannula Guide Channels
- a. Formulation: The guide channel design is based upon the ultrasound system and encourages the needle to align with variable guidelines generated on the system monitor.
- b. Composition: A rigid frame containing evenly spaced through-holes and a connection to the Probe Attachment Bracket.
- ﻥ Functionality: These channels guide a cannula to a set position that aligns with gridlines displayed by the corresponding ultrasound monitor.
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- Probe Attachment Bracket
- a. Formulation: Every bracket is uniquely designed to meet each transducer's specific geometry to maximize the contact surface area and limit the ability for the cannula to shift or rotate about the transducer.
- b. Composition: A mounting structure attached to the Cannula Guide Channels which contains: a surface that fits snugly onto the transducer, a hinge to anchor the Attachment Bracket Lock, a hook to catch the mobile end of the Attachment Bracket Lock.
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- Functionality: This bracket connects the guide channels to the upper side of the ﻥ transducer in a reliable, inflexible manner such that the channels maintain their position and orientation relative to the transducer. This bracket mates with the bracket lock to physically secure the connection to mitigate the effects of impulse motion or jerk movements.
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- Attachment Bracket Lock
- Formulation: This lock is designed to be pulled into tension around the transducer and a. meets each transducer's specific geometry to achieve adequate holding pressure.
- b. Composition: A semi-rigid arm containing two hooks, one hook for anchoring to the hinge of the Attachment Bracket Lock and another hook on the mobile end to latch onto the hook protruding from the Probe Attachment Bracket.
- Functionality: This lock secures the connection between the Probe Attachment Bracket ﻥ and the transducer. The user wraps this lock around the underside of the transducer and hooks it to one side of the Probe Attachment Bracket.
Summary of Non-Clinical Tests Performed on Subject:
Biocompatibility: The disposable Needle Guides and Grids meet ISO 10993-1 biocompatibility and ASCA- Pilot Biocompatibility Guidance requirements for limited contact duration for surface devices of breached or compromised surface external communicating tissue and indirect blood path.
- a. Cytotoxicity ISO 10993-5
- Sensitization ISO 10993-10 b.
- C. Irritation - ISO 10993-10
- Acute Systemic Toxicity— ISO 10993-11 ರ.
- e. Material-Mediated Pyrogenicity- 10993-11 and USP 151
- Direct and Indirect Hemolysis/Hemocompatibility ISO 10993-4 and ASTM F756 f.
Summary of Bench Testing Performed on Subject Device:
Cover breach and probe damage testing - Water leak testing was performed during Design 1) Input, Design Output, and Design Validation to demonstrate material attachment of needle guide over a cover did not cause damage to cover or probe.
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- Retention and movement testing Force testing was performed on needle guide attachment to ensure a minimum force of 8N would not cause the guide to dislodge.
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- Needle drag testing Force testing was performed by passing a cannula through the needle guide to ensure binding would not occur and force was less than a 1.5N threshold.
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- Needle path verification testing Needle guides were tested on test fixtures to ensure needle path falls within the design tolerances specified for the design.
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- Simulated Usability Testing - Simulated use evaluations were performed by customers to ensure the design of the needle guide conforms to the user needs and intended use as well as imaging testing conducted through laboratory evaluations.
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Clinical Test Performed:
Clinical tests were not required to demonstrate substantial equivalence.
Conclusions:
The comparisons of the technological and non-clinical performance characteristics indicate Advance Medical Designs, Inc. Disposable Needle Guides & Grids have the same intended use and its technological characteristics do not raise any different questions of safety or effectiveness, as compared to the legally marketed device(s). The improvements made in designs regarding secure attachment prove to be superior and establish the same level, if not greater, of safety and usage. Therefore, AMD's Needle Guides and Grids are substantially equivalent to the legally marketed predicate device disposable endocavity guide marketed by CIVCO. Since the comparison of bench testing to clinical outcomes, documented through images provided, the subject device and predicate device are substantially equivalent. Thus, AMD's (Advance Medical Designs) Needle Guides and Grid's claim demonstrates the device performs comparably to the predicate device and reference devices that are currently marketed for the same intended use.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.