(28 days)
The 29G Thin Wall K-Pack II Needle being a Hypodermic Single Lumen Needle is a sterile medical device for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
The 29G Thin Wall K-Pack II Needle is a sterile hypodermic single lumen needle, for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polypropylene designed to be connected with a malc connector (nozzle) of a piston syringe.
The provided text describes a 510(k) submission for a medical device, the K-Pack II Needle - 29G Thin Wall. This submission aims to extend an existing product line and focuses on demonstrating substantial equivalence to predicate devices, rather than an in-depth study proving performance against specific acceptance criteria for a novel device.
Therefore, the requested information categories related to acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert involvement, and comparative effectiveness studies are largely not applicable or cannot be extracted in the context of this 510(k) summary, as it is a type of regulatory submission focused on equivalency, not a detailed research study report.
However, I can extract information related to the device's characteristics and the basis for its safety and effectiveness claims.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This section is not applicable in the traditional sense of a clinical or performance study with defined numerical acceptance criteria and a detailed report of device performance against those criteria. The 510(k) process for this device relies on demonstrating substantial equivalence to predicate devices. The "acceptance criteria" are implicitly met by confirming that the new device does not raise new questions of safety or effectiveness compared to the predicates.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary of Claims) |
|---|---|
| Intended Use Equivalence | "The 29G Thin Wall K-Pack II Needle... is a sterile medical device for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin." (Same as predicate devices) |
| Design Equivalence | Substantially equivalent to predicates. |
| Technology/Principle of Operation Equivalence | Substantially equivalent to predicates. |
| Materials Equivalence | Substantially equivalent to predicates. |
| Performance Equivalence | Substantially equivalent to predicates. (No new issues of safety or effectiveness raised by differences). |
| Sterility Assurance Level (SAL) | Achieved SAL of 10-6, validated according to EN 550, ISO 11135, and EN 556-1. |
| Ethylene Oxide Residual Levels | In compliance with EN ISO 10993-7. |
| Biocompatibility | Blood contacting materials tested in accordance with FDA G95-1 and ISO-10993-1. |
| Shelf Life/Expiration Dating | Established at 5 years (same as cleared K-Pack II Needles). |
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable. This document is a regulatory submission for substantial equivalence. It does not describe a "test set" in the context of a performance study with a specific sample size. The claims are based on engineering, manufacturing, and regulatory compliance standards applied to the device design and materials, and comparisons to existing predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not Applicable. As no specific "test set" requiring expert ground truth establishment is described for a performance study, this information is not relevant to this document. The "ground truth" for regulatory approval here is whether the device meets the safety and effectiveness standards through substantial equivalence to legally marketed devices, which is assessed by the FDA.
4. Adjudication Method for the Test Set
Not Applicable. No "test set" with adjudication is mentioned in this submission.
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 document concerns a hypodermic needle and does not involve AI or human "readers" in the context of diagnostic interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. This document concerns a hypodermic needle and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" in this context is established through regulatory standards and established methods for medical device manufacturing and testing. This includes:
- Compliance with international standards: e.g., EN 550, ISO 11135, EN 556-1, EN ISO 10993-7, ISO-10993-1.
- Demonstration of substantial equivalence to previously cleared predicate devices (K984576 and K062608) in terms of intended use, design, technology/principle of operation, materials, and performance.
- Internal testing and validation (e.g., sterilization validation, biocompatibility testing, shelf-life studies) against accepted industry benchmarks and regulatory requirements.
8. The Sample Size for the Training Set
Not Applicable. This document does not concern a machine learning or AI algorithm, so there is no training set mentioned.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set, this is not applicable.
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Körzno
OCT 2 3 2008
510(k) SUMMARY
Prepared for: TERUMO EUROPE N.V. Researchpark Zone 2, Interleuvenlaan 40, 3001 Leuven, BELGIUM
Prepared by: Mrs. M.J. Aerts - Manager Regulatory Affairs Tel. (+32) 16 38 13 53 Fax (+32) 16 40 02 49
September 2008 Date prepared:
Note: Class III Summary & Certification is not applicable for the submission of a Class II device
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II. 510(k) SUMMARY
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II.1. Device Name
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II.2. Reason for Submission
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II.3. Intended Use
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II.4. Description
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II '2 Substantial Equivalence
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II.6. Additional Safety Information
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Ш.7. Conclusion
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510(k) SUMMARY as required by 807.92 Summary of Safety & Effectiveness Information
II.l. Device Name
Proprietary Name K-Pack II Needle - 29G Thin Wall Classification Name Hypodermic Single Lumen Needle 21CFR. Section 880.5570 Classification: Class II
11.2. Reason for Submission
This 510k is being submitted to extend the cleared K-Pack II Needle (K984576) product line. The cannula wall of this 29G needle is thinner than what is currently cleared under the K-Pack II Needle 510k (K062608) for the 29 Gauge needle. In addition, the 29G Thin Wall K-Pack II Needle is packaged in a short case instead of a long one as cleared in K062608. This Special 510k is therefore being submitted due to potential issues of safety and effectiveness specific for a thinner needle and the shorter case. This 510k will provide supporting information that the 29G Thin Wall K-Pack II Needle is safe and effective and an acceptable extension of the current K-Pack II Needle product line.
II.3. Intended Use
The 29G Thin Wall K-Pack II Needle being a Hypodermic Single Lumen Needle is a sterile medical device for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Note: This is the same intended use as the predicate device, K-Pack II Needle – K984576 and 29 Gauge & 30 Gauge K- Pack II Needles (K062608)
II.4. Description
The 29G Thin Wall K-Pack II Needle is a sterile hypodermic single lumen needle, for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polypropylene designed to be connected with a malc connector (nozzle) of a piston syringe.
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11.5. Substantial Equivalence
The 29G Thin Wall K-Pack II Needle is substantially equivalent in intended use, design, technology/principal of operation, materials, and performance to the following cleared devices:
Differences between the devices do not raise any significant issues of safety and effectiveness.
II.6. Additional Safety Information
The sterility of 29G Thin Wall K-Pack II Needle is assured by using a validated sterilization method qualified in accordance with EN 550: "Sterilization of Medical Devices: Validation and routine control of ethylene oxide" and ISO 11135: "Medical Devices: Validation and routine control of ethylene oxide sterilization" to a sterility assurance level (SAL) of 106 as required by EN 556-1: "Sterilization of Medical Devices - Requirements for medical devices to be designated "STERILE" - Part - 1: Requirements for terminally sterilized medical devices" and EN 556-1/AC (2006).
Ethylene oxide residual levels resulting from EtO sterilization are in compliance with EN ISO 10993-7: "Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals"
The 29G Thin Wall K-Pack II Needle, like the standard K-Pack II Needle (K984576), is an Externally Communicating device, Contacting Circulating Blood, Limited Exposure (≤ 24 hrs). The device's blood contacting materials 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".
The expiration dating for the 29G Thin Wall K-Pack II Needle has been established at 5 years which is the same as the cleared K-Pack II Needles.
II.7. Conclusion
In summary, the 29G Thin Wall K-Pack II Needle is substantially equivalent in intended use, design, technology/principal of operation, materials, and performance to the following cleared devices:
Differences between the devices do not raise any new issues of safety or effectiveness.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mrs. MJ Aerts Regulatory Affairs Manager TERUMO Europe N.V. Interleuvenlaan 40 Researchpark Zone 2 Leuven, Belgium 3001
OCT 2 3 2008
Re: K082820
Trade/Device Name: K-Pack II Needle - 29G Thin Wall (hypodermic needle) Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: September 18, 2008 Received: September 25, 2008
Dear Mrs. Aerts:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mrs. Aerts
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chih S. Lin, Ph.D.
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known):
Device Name: K-Pack II Needle - 29G Thin Wall (hypodermic needle)
Indication For Use:
The 29G Thin Wall K-Pack II Needle being a Hypodermic Single Lumen Needle is a sterile medical device for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Charles Biber for HD)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082820
§ 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).