(87 days)
BD Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.
BD pen needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G and 32G) and lengths (4mm, 5mm, 8mm and 12.7mm). BD Pen Needles are sterile (gamma irradiation sterilization), non-toxic and non-pyrogenic. The pen needle assembly consists of a doubled-ended cannula that is assembled into an injection-molded hub using adhesive. The hub has internal threads, which allow it to be screwed onto the pen-injector device. This allows the Non Patient (NP) end of the cannula to penetrate through the rubber septum of the cartridge. The Patient end and NP end of the cannula are lubricated using silicone based lubes for ease of injection and rubber septum penetration. An injection-molded inner shield is assembled over the Patient end of the Cannula to protect the point from damage and accidental needle-sticks. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peel-away (tear drop) label to provide sterile barrier and tamper evidence. The outer cover is also used to remove the hub and cannula from the pen. The peel-away label is pre-printed with information, which includes the lot number and needle gauge / length. The individual needle assemblies are packaged in polybags and / or cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized to an SAL 10 by gamma irradiation. The purpose of this Special 510(k) is to expand the needle range to include the 31G and 32G Extra Thin Wall (XTW) pen needles with PentaPoint™ design. The intended use for the modified device remains the same as the predicate devices. Also it is BD's intent to notify the Agency of a non-significant change to the cannula point bevel geometry from 3 bevels (PentaPoint™).
The provided document describes the BD 31G and 32G Extra Thin Wall (XTW) Pen Needles with PentaPoint™ and their performance testing to demonstrate substantial equivalence to predicate devices. It does not describe a study involving an AI/Machine Learning device or a multi-reader multi-case (MRMC) comparative effectiveness study. Therefore, some of the requested information regarding AI models, experts, adjudication methods, and training sets is not applicable based on the provided text.
Here's an analysis of the provided information, focusing on the acceptance criteria and performance studies for the pen needle:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard & Section) | Device Performance (Metric) | Meets Criteria? |
|---|---|---|
| Tubing diameters (ISO 11608-2, section 4.3.1) | OD and ID requirements met | Yes |
| Patency of lumen (ISO 11608-2, section 4.4) | Stylet (80% ±2% of lumen ID) passes freely | Yes |
| Needle points (ISO 11608-2, section 4.5) | Visually sharp at 2.5X magnification, designed to minimize coring and fragmentation | Yes |
| Type A Needle (length) (ISO 11608-2, section 4.3.2) | Patient end within indicated length ± 1.25 mm | Yes |
| Cannula load test (No pre-conditioning) (ISO 11608-2, section 4.9 and 9; ISO 7864 Section 13.1) | Cannula holds force of 22N for 5 seconds | Yes |
| Cannula load test (with pre-conditioning) (ISO 11608-2, section 4.9 and 9; ISO 7864 Section 13) | Cannula holds force of 22N for 5 seconds | Yes |
| Lubrication (ISO 11608-2, section 4.7) | No visible droplets inside/outside surfaces of cannula | Yes |
| Compatibility Testing (ISO 11608-2, section 4.10) | Connectivity (torque) | Yes |
| Penetration Testing (BD Test Method TP700279) | Not specified (assumed to meet internal standard for substantial equivalence) | Yes |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each bench test. The studies are bench tests, meaning they are conducted in a controlled laboratory environment on the device itself, rather than with human subjects or patient data. Data provenance is not applicable in the sense of country of origin for patient data, as no patient data was used for these tests. The tests were performed internally by Becton, Dickinson and Company.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for these performance metrics is established by the specifications defined in the international standards (ISO 11608-2 and ISO 7864) and the internal BD test method (TP700279), not by expert consensus on clinical data.
4. Adjudication method for the test set
Not applicable. The tests are direct measurements against predefined physical and performance specifications, not subjective interpretations 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 more relevant for imaging or diagnostic devices where human interpretation is involved.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device described is a physical medical device (pen needle), not an algorithm or AI system.
7. The type of ground truth used
The ground truth used for these performance tests are:
- International Standards: ISO 11608-2 (Needle-based injection systems for medical use — Requirements and test methods — Part 2: Needles) and ISO 7864 (Sterile hypodermic needles for single use). These standards define objective, measurable specifications for the physical and functional characteristics of pen needles.
- Internal Test Method: BD Test Method TP700279 for penetration testing. While the details are not provided, it's assumed to be an objective, repeatable test method.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical medical device.
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1 Becton Drive Franklin Lakes, New Jersey 07417 tel: 201.847.6800 www.bd.com
JAN 1 8 2013
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Helping all people live healthy lives
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Date of Summary Preparation: November 08, 2012
- Submitted By: Pasquale Amato
Staff Regulatory Affairs Specialist
Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417
201-847-4513 Phone: Fax: 201-848-8830
Contact Person:
Eileen Hiller Director, Regulatory Affairs 201-847- 4570 Phone: 201-847- 5307 Fax: Email: Eileen Hiller@BD.com
2. Device Name:
Trade Name:
BD 31G and 32G Extra Thin Wall (XTW) Pen Needles with PentaPoint™
Common Names:
Insulin Pen Needle
Classification Name: Needle, Hypodermic, Single Lumen
Classification:
Class II, 21 CFR 880.5570 FMI
3. Predicate Device:
BD Pen Needle- K100005 and K051899 Manufactured by: Becton, Dickinson and Company
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4. Device Description:
BD pen needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G and 32G) and lengths (4mm, 5mm, 8mm and 12.7mm). BD Pen Needles are sterile (gamma irradiation sterilization), non-toxic and non-pyrogenic.
The pen needle assembly consists of a doubled-ended cannula that is assembled into an injection-molded hub using adhesive. The hub has internal threads, which allow it to be screwed onto the pen-injector device. This allows the Non Patient (NP) end of the cannula to penetrate through the rubber septum of the cartridge. The Patient end and NP end of the cannula are lubricated using silicone based lubes for ease of injection and rubber septum penetration. An injection-molded inner shield is assembled over the Patient end of the Cannula to protect the point from damage and accidental needle-sticks. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peel-away (tear drop) label to provide sterile barrier and tamper evidence. The outer cover is also used to remove the hub and cannula from the pen. The peel-away label is pre-printed with information, which includes the lot number and needle gauge / length. The individual needle assemblies are packaged in polybags and / or cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized to an SAL 10 by gamma irradiation.
The purpose of this Special 510(k) is to expand the needle range to include the 31G and 32G Extra Thin Wall (XTW) pen needles with PentaPoint™ design. The intended use for the modified device remains the same as the predicate devices.
Also it is BD's intent to notify the Agency of a non-significant change to the cannula point bevel geometry from 3 bevels (PentaPoint™).
5. Statement of Intended Use/Indications for Use:
BD Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.
Technological Characteristics: 6.
The principal device of this premarket notification is the result of a design change to the predicate devices conducted in accordance with Quality System Regulations. The BD 31G and 32G XTW Pen Needle with PentaPoint™, modified, is equivalent to the predicate devices, given that:
- Has the same intended use and indications for use as the predicate . devices
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- Uses the same operating principles .
- Incorporates the same basic design .
- Is manufactured from the same materials ●
- Is sterilized using the same mode .
- Is sterilized with SAL of 106 .
- Is packaged using same unit and case materials ●
- Same fundamental scientific technology .
The only design differences between the modified BD 31G and 32G XTW Pen Needles with PentaPoint™ and the predicate devices are the inner diameter and needle point.
7. Performance:
Bench tests relating to the performance of the BD 31G and 32G XTW Pen Needle with PentaPoint™ were conducted.
The principal device demonstrated equivalent performance to the predicate devices during bench testing. Bench testing consisted of:
| Tubing diameters | Per ISO 11608-2, section 4.3.1 (tubingdimensions meet OD and ID requirement). | |
|---|---|---|
| Patency of lumen | Per ISO 11608-2, section 4.4 (stylet, having adiameter equivalent to 80% ±2% of lumen IDpasses through freely). | |
| Needle points | Per ISO 11608-2, section 4.5 (visually sharp at2.5X magnification, designed to minimizecoring and fragmentation). | |
| Type A Needle (length) | Per ISO 11608-2, section 4.3.2 (patient endwithin indicated length ± 1.25 mm) | |
| Cannula load test(No pre-conditioning) | Per ISO 11608-2, section 4.9 and 9.ISO 7864 Section 13.1(cannula holds force of22N for 5 seconds). | |
| Cannula load test(with pre-conditioning) | Per ISO 11608-2, section 4.9 and 9.ISO 7864 section 13(cannula holds force of22N for 5 seconds). | |
| Lubrication | Per ISO 11608-2, section 4.7 (no visibledroplets inside/outside surfaces of cannula). | |
| Compatibility Testing | Per ISO 11608-2, section 4.10 (connectivity(torque). | |
| Penetration Testing | Per BD Test Method TP700279 |
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8. Substantial Equivalence:
The vast similarities of the BD 31G and 32G XTW Pen Needles with PentaPoint™ to the predicate devices support the substantial equivalence in intended use, function and basic composition. The testing to voluntary standards, ISO 11608-2 and ISO 7864 provides additional evidence that the BD 31G and 32G XTW Pen Needles with PentaPoint™ is substantially equivalent to the predicate devices in terms of safety, efficacy and performance.
The differences between the BD 31G and 32G XTW Pen Needles with PentaPoint™ and the predicate devices do not raise new issues of safety or effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 18, 2013
Becton Dickinson & Company Ms. Pasquale Amato BD Medical Diabetes Care 1 Becton Drive MC 372 Franklin Lakes NJ 07417-1880
Re: K123300
Trade/Device Name: BD 31G and 32G XTW Pen Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II . Product Code: FMI Dated: December 18, 2012 Received: December 19, 2012
Dear Ms. Amato:
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. 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.
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Page 2 - Ms. Amato
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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Anthong ls min
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K | 2 Z3 OD
Device Name: BD 31G and 32G XTW Pen Needles
Indications For Use:
BD Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) : 上一篇: 上一篇:
Concurrence of CDRH, Office of Device Evaluation (ODE)
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| Date: | 2013.01.18 |
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| for Rick Chapman 14:27:04 -05'00' |
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K123300 |
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§ 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).