(158 days)
The Terumo® Pen Injector Needle 34 is intended for use with a pen injector device for the subcutaneous injection of drugs, including insulin.
The Terumo® Pen Injector Needle 34 is comprised of a double-tapered stainless steel needle cannula that is pointed at both the cartridge interface end, to puncture the cartridge for drug delivery, and the patient interface end, for injection into the patient's body tissue. The patient interface end features a 3-bevel, asymmetrical needle edge.
The cannula tapers from a 29G (0.33 mm) outer diameter at the cartridge interface end to a 34G (0.18 mm) outer diameter at the needle tip (patient interface end). It is normal-walled (min. 0.089 mm inner diameter) at the needle tip, and the internal diameter tapers like the outer diameter (wall thickness is uniform throughout the needle length). The double-pointed needle is attached to a plastic hub which screws on to a compatible pen injector (not supplied with this device).
The needle insertion length (from the glue mount on the hub to the tip of the patient interface end) is 4 mm (5/32"). The length of the needle cartridge side is 6.5 mm (1/4"). The patient interface end (needle tip) is covered by a white plastic needle protector cap (inner needle cap) which is then covered by a clear plastic outer case (outer needle case). The cartridge interface end is then covered with a sealing film.
Just prior to use, the outer needle case is removed and retained for recapping once the injection is completed. The inner needle cap is then removed to expose the needle and the injection administered. After the injection, the user inserts the used needle into the open end of the outer needle case so it can be safely removed from the pen injector and disposed of immediately.
This pen needle device is individually packaged and sterilized by electron beam. It is a manually operated, disposable device intended for single use only.
The provided document is a 510(k) summary for the Terumo® Pen Injector Needle 34. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results of the device meeting specific acceptance criteria in the way an AI/ML device submission would.
Therefore, the information requested in your prompt regarding acceptance criteria and studies (as they relate to AI/ML device performance, such as sample sizes for test sets, ground truth establishment, MRMC studies, standalone performance, etc.) is not present in this document. This document details non-clinical performance and biocompatibility testing for a medical needle, which are distinct from the types of studies typically conducted for AI/ML devices.
However, I can extract the available information regarding the non-clinical tests performed and their general results as presented in the document.
Here's a summary of the available information and a notation on what is not present:
1. A table of acceptance criteria and the reported device performance
The document provides a table of non-clinical tests performed and states whether the device meets the standard or acceptance criteria. Specific numerical acceptance criteria are generally not explicitly stated but are implied by adherence to ISO standards or established criteria based on predicate devices.
| Test | Standard | Reported Device Performance |
|---|---|---|
| Surface finish | ISO 11608-2: 2012, ISO 9626: 1991, A1 2001 | Meets standard |
| Cleanliness | ISO 11608-2: 2012, ISO 9626: 1991, A1 2001 | Meets standard |
| Limits for acidity and alkalinity | ISO 11608-2: 2012, ISO 9626: 1991, A1 2001 | Meets standard |
| Dimensions | ISO 11608-2: 2012, ISO 9626: 1991, A1 2001 | Meets standard |
| Stiffness | ISO 11608-2: 2012, ISO 9626: 1991, A1 2001 | Meets standard |
| Resistance to breakage | ISO 11608-2: 2012, ISO 9626: 1991, A1 2001 | Meets standard |
| Resistance to corrosion | ISO 11608-2: 2012, ISO 9626: 1991, A1 2001 | Meets standard |
| Dimensions for needles | ISO 11608-2: 2012 | Meets standard |
| Determination of flow rate through the needle | ISO 11608-2: 2012 | Meets standard |
| Bond between hub and needle tube | ISO 11608-2: 2012 | Meets standard |
| Needle points | ISO 11608-2: 2012 | Meets standard |
| Freedom from defects | ISO 11608-2: 2012 | Meets standard |
| Lubrication | ISO 11608-2: 2012 | Meets standard |
| Dislocation of measuring point at patient end | ISO 11608-2: 2012 | Meets standard |
| Determination of functional compatibility with needle-based injection systems | ISO 11608-2: 2012 | Meets standard |
| Ease of assembly and disassembly | ISO 11608-2: 2012 | Meets standard |
| Sterility | ISO 11608-2: 2012, ISO 11137-1: 2006 | Meets standard |
| Penetration resistance | Acceptance criteria established based on predicates | Meets acceptance criteria |
| Seal film fitting strength | Acceptance criteria established based on predicates | Meets acceptance criteria |
| Cap-hub fitting strength | Acceptance criteria established based on predicates | Meets acceptance criteria |
Regarding Biocompatibility Testing:
The device underwent biocompatibility testing in accordance with ISO 10993-1 and FDA guidance. All listed tests (Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic toxicity, Pyrogenicity, Hemolysis, Physicochemical Profile) for non-aged and accelerated-aged devices demonstrated that the device is biocompatible.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes non-clinical performance and biocompatibility tests on the device itself, not on patient data.
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)
This information is not applicable/provided. The tests are based on conformity to ISO standards and established engineering criteria, not expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, not for the non-clinical device performance tests described here.
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
This information is not applicable/provided. MRMC studies are used for evaluating diagnostic or treatment interpretation, often involving AI systems. This submission is for a physical medical device (pen injector needle) and does not involve AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. This device is a physical needle and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests is based on International Organization for Standardization (ISO) standards and established internal acceptance criteria derived from predicate devices. For biocompatibility, it's based on ISO 10993-1 and FDA guidance.
8. The sample size for the training set
This information is not applicable/provided. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable/provided. There is no "training set" for this device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure in profile, with three faces overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 5, 2014
Mr. Phillip Michael Lester Regulatory Affairs Specialist Terumo Medical Corporation 950 Elkton Boulevard ELKTON MD 21921
Re: K140516
Trade/Device Name: Terumo® Pen Injector Needle 34 Regulation Number: 21 CFR 880.5570 Regulation Name: Needle, Hypodermic, Single Lumen Regulatory Class: II Product Code: FMI Dated: July 8, 2014 Received: July 9, 2014
Dear Mr. Lester:
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 - Mr. Lester
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,
Mary S. Runner -S
Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140516
Device Name The Terumo® Pen Injector Needle 34
Indications for Use (Describe)
The Terumo® Pen Injector Needle 34 is intended for use with a pen injector device for the subcutaneous injection of drugs, including insulin.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
× Over-The-Counter Use (21 CFR 801 Subpart C)
Digitally signed by Richard C.
Date: 2014.08.01 14:09:47 -04'00'
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Chapman -S
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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SECTION 5 - 510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
Summary of Safety and Effectiveness
| A. Submitter Information. | 39 |
|---|---|
| B. Device Name. | 40 |
| C. Predicate Device. | 40 |
| D. Reason for 510(k) Submission. | 40 |
| E. Device Description. | 40 |
| F. Intended Use. | 41 |
| G. Substantial Equivalence. | 41 |
| H. Nonclinical Tests. | 45 |
| I. Clinical Tests. | 47 |
| J. Conclusion. | 47 |
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TERUMO CORPORATION Terumo® Pen Injector Needle 34 Section 5. 510(k) Summary
510(k) SUMMARY
A. SUBMITTER INFORMATION (807.92(a)(1))
| Prepared by: | Phillip Michael Lester |
|---|---|
| Regulatory Affairs Specialist | |
| Terumo Medical Corporation | |
| Tel. (410) 392-7321 | |
| Fax (410) 398-6079 |
| Prepared for: | Owner/OperatorTerumo Corporation44-1, 2-Chome, HatagayaShibuya-Ku, Tokyo, Japan 151-0072Registration Number: 8010026 |
|---|---|
| Manufacturer and Sterilization Facility (Applicant)Kofu Factory of Terumo Corporation1727-1, Tsuijiarai, Showa-ChoNakakoma-Gun, Yamanashi, Japan 409-3853Registration Number: 9681835 | |
| Contact Person: | Phillip Michael LesterRegulatory Affairs SpecialistTerumo Medical Corporation950 Elkton BoulevardElkton, MD 21921Tel. (410) 392-7321Fax (410) 398-6079E-mail: philmichael.lester@terumomedical.com |
Date prepared: April 4, 2014
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B. DEVICE NAME (807.92(a)(2))
| Proprietary Name: | Terumo® Pen Injector Needle 34 (or similar) |
|---|---|
| Common Name: | Hypodermic single lumen needle |
| Classification Name: | Needle, Hypodermic, Single Lumen |
| Classification Panel: | General Hospital |
| Regulation: | 21 CFR 880.5570 |
| Product Code: | FMI |
| Classification: | Class II |
C. PREDICATE DEVICE (807.92(a)(3))
The legally marketed device(s) to which substantial equivalence is claimed is/are:
-
- K123300 BD 31G and 32G Extra Thin Wall (XTW) Pen Needles with PentaPoint™, manufactured by Becton, Dickinson and Company, New Jersey.
-
- K052561 Terumo® Micro Tapered Pen Needle, manufactured by Kofu Factory of Terumo Corporation, Japan.
D. REASON FOR 510(K) SUBMISSION
This 510(k) is being submitted due to design modifications to the previously cleared device (K052561) that would prompt a new submission: 1) new needle gauge size, 34G (0.18 mm); 2) new needle insertion length of 4 mm (from previous 5 mm, cleared under K052561); 3) change in sterilization method (from gamma to electron beam); and 4) a change in the indications for use from the previously cleared device. Therefore, this Traditional 510(k) is being submitted for modifications to the current device (K052561) that do not qualify for Special 510(k).
E. DEVICE DESCRIPTION (807.92(a)(4))
The Terumo® Pen Injector Needle 34 is comprised of a double-tapered stainless steel needle cannula that is pointed at both the cartridge interface end, to puncture the cartridge for drug delivery, and the patient interface end, for injection into the patient's body tissue. The patient interface end features a 3-bevel, asymmetrical needle edge.
The cannula tapers from a 29G (0.33 mm) outer diameter at the cartridge interface
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end to a 34G (0.18 mm) outer diameter at the needle tip (patient interface end). It is normal-walled (min. 0.089 mm inner diameter) at the needle tip, and the internal diameter tapers like the outer diameter (wall thickness is uniform throughout the needle length). The double-pointed needle is attached to a plastic hub which screws on to a compatible pen injector (not supplied with this device).
The needle insertion length (from the glue mount on the hub to the tip of the patient interface end) is 4 mm (5/32"). The length of the needle cartridge side is 6.5 mm (1/4"). The patient interface end (needle tip) is covered by a white plastic needle protector cap (inner needle cap) which is then covered by a clear plastic outer case (outer needle case). The cartridge interface end is then covered with a sealing film.
Just prior to use, the outer needle case is removed and retained for recapping once the injection is completed. The inner needle cap is then removed to expose the needle and the injection administered. After the injection, the user inserts the used needle into the open end of the outer needle case so it can be safely removed from the pen injector and disposed of immediately.
This pen needle device is individually packaged and sterilized by electron beam. It is a manually operated, disposable device intended for single use only.
F. INTENDED USE (807.92(a)(5))
The Terumo® Pen Injector Needle 34 is intended for use with a pen injector device for the subcutaneous injection of drugs, including insulin.
G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))
The Terumo® Pen Injector Needle 34, subject of this Traditional 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to:
-
- K123300 BD 31G and 32G Extra Thin Wall (XTW) Pen Needles with PentaPoint™, manufactured by Becton, Dickinson and Company, New Jersey.
-
- K052561 Terumo® Micro Tapered Pen Needle, manufactured by Kofu Factory of Terumo Corporation, Japan.
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A comparison of the intended use/indications for use and technological characteristics is summarized in the table on the following page. The minor differences of indications for use and the technological differences do not impact the safety and effectiveness of the device.
Note: A statement of substantial equivalence to another product is required by 21CFR807.87, and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is, therefore, not related to the coverage of any patent, and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the Commissioner of the FDA has stated, " ...a determination of substantial equivalence under the federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatever on the resolution of patent infringement suits" 42 Fed. Reg. 42,520, et seq. (1977)
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| DeviceCharacteristic | New Device: Terumo® Pen InjectorNeedle 34 | Predicate: TERUMO® MicroTapered Pen Needle (K052561) | Predicate: BD 31G and 32G ExtraThin Wall (XTW) Pen Needles withPentaPoint™ (K123300) | |
|---|---|---|---|---|
| Manufacturer | Kofu Factory of Terumo Corporation | Kofu Factory of Terumo Corporation | Becton, Dickinson and Company | |
| Intended Use | The Terumo® Pen Injector Needle34 is intended for use with a peninjector device for the subcutaneousinjection of drugs, including insulin. | The TERUMO® Micro taperedpen needle is intended for use witha pen injector device for thesubcutaneous injection of insulin.It is indicated for general use andfor pediatric patients. | BD Pen Needle is intended for usewith pen injector device forsubcutaneous injection of drugs,including insulin and exenatide. | |
| OperationPrinciple | Manual | Manual | Manual | |
| Design /Construction | • Needle assembly (cannula, needlehub, protector cap)• Designed to fit specified peninjectors (new ISO 11608-2:2012compatibility requirements) | • Needle assembly (cannula, needlehub, protector cap)• Designed to fit Type A peninjectors (ISO 11608-2:2000) | • Needle assembly (cannula, needlehub, protector cap)• Designed to fit Type A peninjectors | |
| Materials | • Cannula – Stainless Steel• Lubricant - Silicone Oil• Adhesive – Polyacrylate• Needle Hub – Polypropylene• Protector Cap – Polyethylene• Outer Case – Polypropylene• Sealing Film – Kraft Paper | • Cannula – Stainless Steel• Lubricant - Silicone Oil• Adhesive – Polyacrylate• Needle Hub – Polypropylene• Protector Cap – Polyethylene• Outer Case – Polypropylene• Sealing Film – Kraft Paper | • Cannula – Stainless Steel• Lubricant - Silicone BasedNote: this is the information publiclyavailable for the device. | |
| Package | • Plastic outer case• Sealing Film• Shelf box | • Plastic outer case• Sealing Film• Shelf box | • Plastic outer case• Sealing Film• Shelf box | |
| DeviceCharacteristic | New Device: TerumoⓇ Pen InjectorNeedle 34 | Predicate: TERUMO® MicroTapered Pen Needle (K052561) | Predicate: BD 31G and 32G ExtraThin Wall (XTW) Pen Needles withPentaPoint™ (K123300) | |
| Specifications | Taper | Double Tapered Design; 29G (0.33 mm) O.D. > 34G (0.18 mm) O.D. | Double Tapered Design; 28G (0.35 mm) O.D. > 33G (0.20 mm) O.D. | None; remains straight throughout |
| NeedleLength | 4 mm (5/32") – Patient Interface6.5 mm (1/4") – Cartridge Interface | 5 mm (3/16") – Patient Interface5.5 mm (7/32") – Cartridge Interface | 4mm for 32G; 5mm and 8mm for31G – Patient Interface | |
| EffectiveGauge | 34G | 33G | 31 and 32G | |
| Tip Configuration | Patient-side: Asymmetrical 3-bevelCartridge-side: Bent (Eccentric) | Patient-side: Asymmetrical 3-bevelCartridge-side: Bent (Eccentric) | Patient-side: 5-bevel | |
| Wall Type | Normal Wall (min. 0.089 mm) atdistal tip (patient interface end)* | Normal Wall (min. 0.089 mm) atdistal tip (patient interface end) | Extra Thin Wall | |
| Sterilization | E-beam radiation (validated inaccordance with ISO 11137-1 toachieve SAL 10⁻⁶) | Gamma radiation (validated inaccordance with ISO 11137-1 toachieve SAL 10⁻⁶) | Gamma radiation |
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*The I.D. tapers like the O.D. of the device. The I.D. is the distal portion of the needle. The wall thickness of the cannula remains uniform throughout.
The proposed device and the predicate devices are classified under 21 CFR 880.5570, which states: "A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the surface of the skin."
The proposed device and the predicate devices use statements similar to the excerpt from the regulation. The intended use of the devices are identical (the injection of fluids subcutaneously), and the indications only differ slightly between the proposed device and the predicates. The proposed device only differs from K 123300 in that exenatide is not included. However, the Terumo device is otherwise identical in indications for use to the BD Pen Needle (K123300).
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H. NON CLINICAL TESTS (807.92(b)(1))
Performance
Performance testing was conducted to ensure the safety and effectiveness of the Terumo® Pen Injector Needle 34 throughout the shelf life, verify conformity to the applicable parts of ISO standards, and demonstrate substantial equivalence to the predicate device. No new issues of safety and effectiveness were raised with the testing performed. The following performance tests were performed:
| Test | Standard | Result |
|---|---|---|
| Surface finish | ISO 11608-2: 2012,ISO 9626: 1991, A1 2001 | Meetsstandard. |
| Cleanliness | ||
| Limits for acidity and alkalinity | ||
| Dimensions | ||
| Stiffness | ||
| Resistance to breakage | ||
| Resistance to corrosion | ||
| Dimensions for needles | ISO 11608-2: 2012 | Meetsstandard. |
| Determination of flow rate through theneedle | ||
| Bond between hub and needle tube | ||
| Needle points | ||
| Freedom from defects | ||
| Lubrication | ||
| Dislocation of measuring point at patientend | ||
| Determination of functional compatibilitywith needle-based injection systems | ||
| Ease of assembly and disassembly | ||
| Sterility | ISO 11608-2: 2012,ISO 11137-1: 2006 | Meetsstandard. |
No deviations from recognized consensus ISO standards were identified in the testing to standards, except where the design of the needle resulted in a modified method or acceptance criterion.
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Additionally, performance testing other than to the above ISO Standards was performed on the device. The device complies with the acceptance criteria established based on the predicates:
| Performance Test | Results |
|---|---|
| Penetration resistance | Meets acceptance criteria |
| Seal film fitting strength | Meets acceptance criteria |
| Cap-hub fitting strength | Meets acceptance criteria |
Performance testing demonstrates that the Terumo® Pen Injector Needle 34 conforms to the recognized consensus ISO standards, is substantially equivalent to the predicate devices, and is acceptable for clinical use throughout the shelf life.
Biocompatibility
In accordance with ISO 10993-1, the Terumo® Pen Injector Needle 34 is classified as: Externally Communicating Device, Blood Path Indirect, Short Term (<24 hours) Use, as the cannula is immediately withdrawn after injection into the body. The finished device's blood/body contacting parts were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and Draft Guidance for Industry and Food and Drug Administration Staff - Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." Screening tests were performed on accelerated aged devices to show that the biocompatibility is maintained throughout the shelf life of the product. Results of the testing demonstrate that the device is biocompatible throughout the shelf life of the product.
| Non-aged, sterile, whole device | |
|---|---|
| Cytotoxicity | |
| Sensitization | |
| Intracutaneous reactivity (acute) | |
| Systemic toxicity (acute) | |
| Pyrogenicity | |
| Hemolysis | |
| Physicochemical Profile (USP <661> and FTIR) |
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| Accelerated-aged (5 years), sterile, whole device |
|---|
| Cytotoxicity |
| Hemolysis |
| Physicochemical Profile (USP <661> and FTIR) |
Sterilization
The sterility of the device is assured using a sterilization method validated in accordance with ANSI/AAMI/ISO 11137 - Medical Devices - Validation and Routine Control of Radiation Sterilization. Though the sterilization method has changed from gamma irradiation to electron beam irradiation for the modified device, the Terumo® Pen Injector Needle 34 is sterilized to provide a Sterility Assurance Level (SAL) of 10 . Performance testing demonstrated that the device functionality is substantially equivalent, and biocompatibility testing confirmed that the device is still biocompatible.
Risk Analysis
A Product Risk Analysis was conducted in accordance with ISO 14971, taking into account the modifications to the previous device, and it was determined that any new risks were adequately captured and mitigated.
I. CLINICAL TESTS (807.92(b)(2))
This 510(k) does not include data from clinical tests.
J. CONCLUSION (807.92(b)(3))
In summary, the Terumo® Pen Injector Needle 34, subject of this 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to:
-
- K123300 BD 31G and 32G Extra Thin Wall (XTW) Pen Needles with PentaPoint™, manufactured by Becton, Dickinson and Company, New Jersey.
-
- K052561 Terumo® Micro Tapered Pen Needle, manufactured by Kofu Factory of Terumo Corporation, Japan.
There is no significant difference that raises any new issues of safety and effectiveness.
§ 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).