(28 days)
The BD Intraosseous Vascular Access System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adult and pediatric patients, and the distal femur in pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
The BD Intraosseous Vascular Access System provides clinicians and emergency personnel with access to the intraosseous space for resuscitation and lifesaving fluid delivery for up to 24 hours. The BD Intraosseous Vascular Access System consists of the following:
•a single use hypodermic needle (with needle safety cap),
•a powered or manual driver to assist with needle insertion,
•an extension set, and
•an adhesive-backed securement dressing.
For insertions using the powered driver, the hypodermic needle includes a needle hub that mates with a stylet connected to a drive adapter hub. The drive adapter hub includes a ferromagnetic material that is attracted by the magnet in the powered driver and attaches to the powered driver prior to needle insertion. The BD Intraosseous Vascular Access System is an easy-grip, hand-held, battery-powered device used to assist in the insertion of the subject device needle through the bone cortex. The assembly of the hypodermic needle and stylet with connected drive adapter hub is referred to as the needle set.
This is a 510(k) summary for a medical device called the "BD Intraosseous Vascular Access System EMS Powered Driver". This document details various aspects of the device and its claim of substantial equivalence to a predicate device. However, it does not contain a study proving the device meets acceptance criteria derived from a clinical trial or a formal comparative effectiveness study (MRMC study) as would be typical for an AI/ML powered device.
Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device by comparing technical characteristics and performance based on adherence to recognized consensus standards and in-house protocols. This is a common pathway for medical device clearance when significant changes are not made that would require new clinical data.
Therefore, many of the specific points you requested (like sample size for test set, number of experts for ground truth, adjudication methods, MRMC study effect size, standalone performance, training set size, and ground truth establishment for training set) are not applicable to the information provided in this 510(k) summary because it primarily describes a device modification with performance demonstrated through engineering verification and validation, not a clinical study to assess diagnostic or therapeutic accuracy of an AI.
However, I can extract the acceptance criteria and performance information as presented for this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "The subject device met all predetermined acceptance criteria derived from the above listed reference standards and demonstrated substantially equivalent performance as compared to the cited predicated device."
It lists numerous standards and guidance documents that cover various aspects of the device's performance, safety, and functionality. The "acceptance criteria" for this type of submission are meeting the requirements of these standards. The "reported device performance" is that it did meet these criteria, thus demonstrating substantial equivalence.
Since specific quantitative acceptance criteria and corresponding reported values are not presented in a table format in the provided text, I will summarize the categories of performance assessed based on the listed standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Risk Management (ISO 14971:2019) | All identified risks mitigated using well-established methods. |
| Basic Safety & Essential Performance (ANSI AAMI ES 60601-1:2012) | Met all general requirements. |
| Electromagnetic Disturbances (IEC 60601-1-2:2014) | Met requirements for electromagnetic compatibility. |
| Usability (IEC 60601-1-6:2013, FDA Guidance 2005) | Met requirements for usability and human factors. |
| Emergency Medical Services Environment (IEC 60601-1-12:2020) | Met requirements for use in EMS environments. |
| Battery Safety (IEC 60086-4:2019, UN3091, UN3090, UN38.3) | Met safety requirements for lithium batteries and transport. |
| Cleaning & Reprocessing (AAMI TIR30:2011, FDA Guidance) | Met requirements for intermediate level disinfection. |
| Software Validation (FDA Guidance 2005, 2002, 2017) | Software validation was performed according to guidelines. |
| Packaging & Sterilization (ISO 11607-1:2019, ISTA 1G:2014) | Met requirements for packaging and transport. |
| Labeling (ISO 15223-1, 2:2016) | Met requirements for medical device labels. |
| Mechanical Performance (implied throughout the document, e.g., service life, insertion technique) | Demonstrated equivalence to predicate, 1500 insertions at 10 seconds per insertion service life confirmed. |
| Material Biocompatibility (implied by comparing materials and stating no new questions of safety) | Materials (co-polyester and 30% Glass-fiber reinforced polypropylene) deemed equivalent for non-patient contacting parts or no new risks introduced. |
2. Sample Size Used for the Test Set and the Data Provenance
This document does not specify a "test set" in the context of clinical data for an AI/ML device. The testing conducted was largely engineering verification and validation against standards and internal protocols to ensure the device modifications (changes in driver shape, materials, battery, software firmware, and switch) did not raise new questions of safety or effectiveness compared to the predicate device. Therefore, clinical trial-style sample sizes and data provenance (e.g., country of origin, retrospective/prospective) are not detailed here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is not an AI/ML diagnostic or prognostic device requiring expert-established ground truth from a test set of medical cases. Performance was assessed against engineering and safety standards.
4. Adjudication Method for the Test Set
Not applicable. See point 3.
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 a hardware device (an intraosseous vascular access system powered driver), not an AI/ML solution designed to assist human readers or clinicians with interpretation tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm. Its function is to assist in inserting a needle, not to provide diagnostic or prognostic information.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the conventional sense for AI/ML devices. The "ground truth" for this device's performance is adherence to established engineering, safety, and performance standards as outlined in the numerous ISO, IEC, ANSI AAMI, and FDA guidance documents.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML system that utilizes a training set of data.
9. How the Ground Truth for the Training Set was Established
Not applicable. See point 8.
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Image /page/0/Picture/0 description: The image contains 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.
November 10, 2022
Bard Access Systems Nasreen Al-Quaid Staff Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, UT
Re: K223198
Trade/Device Name: BD Intraosseous Vascular Access System EMS Powered Driver (D001003) Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: MHC Dated: October 11, 2022 Received: October 13, 2022
Dear Nasreen Al-Quaid:
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.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
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Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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-safetyreporting-combination-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-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-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-devices/device-advicecomprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joyce M. Whang -S
CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices 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) K223198
Device Name
BD Intraosseous Vascular Access System EMS Powered Driver (D001003)
Indications for Use (Describe)
The BD Intraosseous Vascular Access System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adult and pediatric patients, and the distal femur in pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
| 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) |
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Bard Access Systems, Inc. (Bard has joined BD) Special 510(k) Premarket Notification BD Intraosseous Vascular Access System EMS Powered Driver 510(k) Summary
510(k) Summary
21 CFR 807.92(a)
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (1)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:
| Submitter Name: | Bard Access Systems, Inc. (Bard has joined BD) | |
|---|---|---|
| Submitter Address: | 605 North 5600 WestSalt Lake City, UT 84116 | |
| GeneralProvisions | Contact Person: | Nasreen A. Al-QuaidStaff Regulatory Affairs Specialist |
| Telephone Number: | 484.569.2865 | |
| Email: | Nasreenara.alquaid@bd.com | |
| Date of Preparation: | 11/07/2022 | |
| Trade Name: | ||
| SubjectDevice | Common Name: | Intraosseous Infusion System |
| Regulation Number: | 21 CFR §880.5570 | |
| Regulation Classification Name: | Hypodermic, Single Lumen Needle | |
| Regulatory Class: | II |
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| Product Code: | MHC | |
|---|---|---|
| Classification Panel: | General Hospital | |
| Trade Name: | BD Intraosseous Infusion System | |
| Common Name: | Intraosseous Infusion System | |
| Regulation Number: | 21 CFR §880.5570 | |
| PredicateDevice | Regulation Classification Name: | Hypodermic, Single Lumen Needle |
| Regulatory Class: | II | |
| Product Code: | MHC | |
| Classification Panel: | General Hospital | |
| 510(k) Status: | K203193 (Concurrence date: March 4, 2021) | |
| DeviceDescription | The BD Intraosseous Vascular Access System provides clinicians and emergency personnel with access to the intraosseous space for resuscitation and lifesaving fluid delivery for up to 24 hours. The BD Intraosseous Vascular Access System consists of the following:•a single use hypodermic needle (with needle safety cap),•a powered or manual driver to assist with needle insertion,•an extension set, and•an adhesive-backed securement dressing.For insertions using the powered driver, the hypodermic needle includes a needle hub that mates with a stylet connected to a drive adapter hub. The drive adapter hub includes a ferromagnetic material that is attracted by the magnet in the powered driver and attaches to the powered driver prior to needle insertion. The BD Intraosseous Vascular Access System is an easy-grip, hand-held, battery-powered device used to assist in the insertion of the subject device needle through the bone cortex. The assembly of the hypodermic needle and stylet with connected drive adapter hub is referred to as the needle set. |
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| Intended Use | The BD Intraosseous Vascular Access System is intended to provide clinicians and emergency personnel with access to the intraosseous space. |
|---|---|
| Indicationsfor Use | The BD Intraosseous Vascular Access System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adult and pediatric patients, and the distal femur in pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. |
| TechnologicalCharacteristics | At a high level, the subject device, BD Intraosseous Vascular Access System EMS Powered Driver and the cited predicate device are based on the following same technological and use elements:Intended Use, Indications for Use, Target Patient Population Reusable Powered Intraosseous Driver- used to provide intraosseous access Power Driver Attachment to Needle - at distal end of device and same insertion technique |
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K223198
Page 4 of 11
| • | Use of the same Needle Set Configurations – choice of use based on tissue depth | |||
|---|---|---|---|---|
| • | Use of LED Battery Display - indication the status of the battery | |||
| • | Use of an Operating Switch to run the device | |||
| • | Use of a Motor and Circuit Board Assembly and Microcontroller ARM Processor | |||
| • | Use of Lithium-ion Batteries to run the device | |||
| The modifications made to the predicate device include modifications to the design and technology, software and labeling. The following technological differences exist between the subject and predicate devices: | ||||
| 1. | Design and Technology; | |||
| • | Change in driver shape, placement of LED battery indicator lights &operating switch. | |||
| • | Housing and Rear Cap material difference due to shape modification | |||
| • | Hardware and battery changes to facilitate replaceable battery | |||
| 2. | Software: Modification to structure of software (firmware). | |||
| 3. | Labeling: Separate IFU to support charging differences of the device | |||
| The following tables provides a summary comparison between the subject and predicate device. | ||||
| Attribute | Subject DeviceBD Intraosseous Vascular AccessSystem EMS Powered Driver | Predicate deviceBD Intraosseous Infusion System(K203193) | Discussion of SubstantialEquivalence | |
| Owner | Bard Access Systems, Inc. | Bard Access Systems, Inc. | Identical | |
| 510(k) status | Subject of this 510(k) | K203193 | Identical | |
| Intended Use | The BD Intraosseous Vascular AccessSystem is intended to provide clinicians | The BD Intraosseous Vascular AccessSystem is intended to provide clinicians | Identical | |
| Indications foruse | and emergency personnel with accessto the intraosseous spaceThe BD Intraosseous Vascular AccessSystem provides intraosseous access inthe proximal tibia, distal tibia andhumeral head (proximal humerus) ofadult and pediatric patients, and thedistal femur in pediatric patients whenintravenous access is difficult orimpossible to obtain in emergent, urgent,or medically necessary cases for up to24 hours. | and emergency personnel with access tothe intraosseous spaceThe BD Intraosseous Vascular AccessSystem provides intraosseous access inthe proximal tibia, distal tibia andhumeral head (proximal humerus) ofadult and pediatric patients, and thedistal femur in pediatric patients whenintravenous access is difficult orimpossible to obtain in emergent, urgent,or medically necessary cases for up to24 hours. | Identical | |
| PoweredDriver Use | Reusable | Reusable | Identical | |
| IntendedPatientPopulation | Adults and Pediatrics who require short-term (less than 30 days intraosseousinfusion therapy | Adults and Pediatrics who require short-term (less than 30 days intraosseousinfusion therapy | Identical | |
| General DeviceDescription | The BD Intraosseous Vascular AccessSystem provides clinicians andemergency personnel with access to theintraosseous space for resuscitation andlifesaving fluid delivery for up to 24hours. The BD Intraosseous VascularAccess System consists of the following:•a single use hypodermic needle (withneedle safety cap),•a powered or manual driver to assistwith needle insertion,•an extension set, and•an adhesive-backed securementdressing.For insertions using the powered driver,the hypodermic needle includes aneedle hub that mates with a styletconnected to a drive adapter hub. Thedrive adapter hub includes a magneticinsert that attaches to the powereddriver prior to needle insertion. The BDIntraosseous Vascular Access System isan easy-grip, hand-held, battery-powered device used to assist in theinsertion of the subject device needlethrough the bone cortex. The assemblyof the hypodermic needle and stylet withconnected drive adapter hub is referredto as the needle set. | The BD Intraosseous Vascular AccessSystem provides clinicians andemergency personnel with access to theintraosseous space for resuscitation and | Identical | |
| Insertion Site | Adults: proximal tibia, distal tibia, andproximal humerusPediatrics: proximal tibia, distal tibiaproximal humerus, and the distal femur | Adults: proximal tibia, distal tibia, andproximal humerusPediatrics: proximal tibia, distal tibiaproximal humerus, and the distal femur | Identical | |
| Needle SetConfigurations | 15mm (0-10 mm tissue depth)25mm (0-20 mm tissue depth)35mm (10-30 mm tissue depth)45mm (20-40 mm tissue depth)55mm (30-50 mm tissue depth) | 15mm (0-10 mm tissue depth)25mm (0-20 mm tissue depth)35mm (10-30 mm tissue depth)45mm (20-40 mm tissue depth)55mm (30-50 mm tissue depth) | Identical | |
| PoweredDriverAttachment toNeedle | Ferromagnetic material that is attractedby the magnet in the powered driver atthe distal end of device | Ferromagnetic material that is attractedby the magnet in the powered driver atthe distal end of device | Identical | |
| PoweredDriverTechnique toInsert | Powered: Manually press needle setthrough soft tissue to bone. Checkblack depth marks. Drill needle setthrough bone until change in pressureis felt or to desired depth. Removedriver.Remove stylet. Connect IV extensionset. Check placement. Monitor site. | Powered: Manually press needle setthrough soft tissue to bone. Checkblack depth marks. Drill needle setthrough bone until change in pressureis felt or to desired depth. Removedriver.Remove stylet. Connect IV extensionset. Check placement. Monitor site. | Identical | |
| PoweredDriver Design -Shape | In-Line Driver Shape | Traditional Drill Shape | Modification in Shape(Housing and Addition ofRear Threaded Cap).Changes to the housingshape do not raise new ordifferent questions of safetyor effectiveness. | |
| PoweredDriver LEDBattery Display | Placement modification of LED BatteryIndicator light, indicating the status ofthe battery | LED Battery Indicator light, indicating thestatus of the battery | Modification in Placementdue to Shape | |
| PoweredDriver Design -Materials | Co-polyester and 30% Glass-fiberreinforced polypropylene | Copolyester | Modification in Material(Housing and Rear ThreadedCap). Changes to the drivermaterial are not patentcontacting and do not raisenew or different questions ofsafety or effectiveness. | |
| Power DriverDesign -Switch | Power Switch - Button | Power Switch - Trigger | Modification in Ergonomicsof the Power Switch.Changes to the triggerlocation do not raise new ordifferent questions of safetyor effectiveness. | |
| PoweredDriver Design -InternalHardware | Redesigned Motor and Circuit boardAssembly | Motor and Circuit board Assembly | Redesigned to supportbattery type and shapechange. Changes to thehardware do not raise new ordifferent questions of safetyor effectiveness. | |
| PoweredDriver BatteryType | Lithium-ion BatteriesPrimary, (Replaceable), Removable | Lithium-ion BatterySecondary (Rechargeable),Non-Removeable | Modification in Battery Type.Changes to the battery typedo not raise new or differentquestions of safety oreffectiveness. | |
| PoweredDriverSoftware | Updated Firmware developed for 32-bitMicrocontroller ARM processor | Firmware developed for 32-bitMicrocontroller ARM processor | Firmware was developedusing the same architectureto support hardwarechanges. Changes to thefirmware do not raise new ordifferent questions of safetyor effectiveness. | |
| PoweredDriverCleaningMethod | Intermediate level disinfection | Intermediate level disinfection | Identical | |
| PoweredDriver ServiceLife | 1500 insertions at 10 seconds per insertion | 1500 insertions at 10 seconds per insertion | Identical | |
| A risk analysis was conducted in accordance with ISO 14971, Medical Devices - Risk Management for Medical Devices todetermine the impact of design & technology, software and labeling modifications to the device, the BD IO EMS PoweredDriver. Attributes identified that presented different risks as per the risk analysis were mitigated using well-establishedmethods and the following consensus standards for general use, listed below. Therefore, these differences in technologicalcharacteristics in the subject devices do not raise any significant changes in safety and effectiveness as compared to thepredicate design. | ||||
| PerformanceTests | Applicable verification and validation tests have been performed in accordance with Design Controls as per 21 CFR §820.30.The following guidance documents and standards in conjunction with in-house protocols were used to determine appropriatemethods for evaluating the performance of the device: | |||
| DocumentNumber | Revision | Title | ||
| ISO 14971 | 2019 | Medical Devices - Risk Management for Medical Devices | ||
| ANSI AAMI ES60601-1 | 2012 | Medical electrical equipment - Part 1: General requirements for basic safetyand essential performance |
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| IEC 60601-1-2 | 2014 | Medical electrical equipment - Part 1-2: General requirements for basicsafety and essential performance - Collateral Standard: Electromagneticdisturbances -Requirements and tests |
|---|---|---|
| IEC 60601-1-6 | 2013 | Medical electrical equipment - Part 1-6: General requirements for basicsafety and essential performance - Collateral standard: Usability |
| IEC 60601-1-12 | 2020 | Medical electrical equipment - Part 1-12: General requirements for basicsafety and essential performance - Collateral Standard: Requirements formedical electrical equipment and medical electrical systems intended foruse in the emergency medical services environment |
| IEC 60086-4 | 2019 | Primary batteries - Part 4: Safety of lithium batteries. |
| UN3091 | N/A | Lithium Battery Guidance Document |
| UN3090 | N/A | Lithium Battery Guidance Document |
| UN38.3 | N/A | UN Recommendations on the Transport of Dangerous Goods |
| AAMI TIR30 | 2011(R2016) | Cleaning Reusable Medical Device |
| FDA Guidance | N/A | FDA Guidance Document, Reprocessing Medical Devices in Health CareSetting |
| FDA Guidance | 2005 | Applying Human Factors and Usability Engineering |
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| FDA Guidance | 2005 | Guidance for the Content of Premarket Submissions for Software Containedin Medical Devices | |
|---|---|---|---|
| FDA Guidance | 2002 | General Principles of Software Validation, Guidance for Industry and FDAStaff | |
| FDA Guidance | 2017 | Deciding When to Submit a 510(k) for a Software Change to an ExistingDevice | |
| ISO 11607-1 | 2019 | Packaging for terminally sterilized medical devices – Part 1: Requirementsfor materials, sterile barrier systems and packaging systems | |
| ISTA 1G | 2014 | Packaged-Products Weighing 150 lb (68 Kg) Or Less (Random Vibration) | |
| ISO 15223-1, 2 | 2016 | Symbols to be Used with medical device labels | |
| The subject device met all predetermined acceptance criteria derived from the above listed reference standards anddemonstrated substantially equivalent performance as compared to the cited predicated device. | |||
| Summary ofSubstantialEquivalence | Based on the risk management activities, intended use, technological characteristics, and performance testing, the subject, BDIO EMS Powered Driver demonstrated to be substantial equivalent for its intended use and fundamental scientific technologyas the cited predicate device. |
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).