(173 days)
The 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 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 male connector (nozzle) of a piston syringe or an intravascular administration set.
The provided text describes a 510(k) submission for the K-Pack II Needle, asserting its substantial equivalence to a predicate device. The information focuses on comparison of design, materials, intended use, and performance standards. However, it does not contain information about a study proving specific acceptance criteria, but rather demonstrates compliance with international standards and biocompatibility.
Due to the nature of the document, which is a 510(k) summary for a hypodermic needle seeking substantial equivalence, it does not involve the type of clinical or performance study with acceptance criteria and reported device performance that would be typical for more complex medical devices, especially software or AI-driven ones. The "acceptance criteria" here are primarily compliance with established standards and demonstrated equivalency.
Therefore, many of the requested fields cannot be directly extracted from the provided text for this specific device.
Here's an attempt to answer based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
For a hypodermic needle seeking 510(k) clearance, the "acceptance criteria" are generally compliance with relevant international and national standards, and demonstration of substantial equivalence to a predicate device. The performance is assessed against these standards and through direct comparison.
| Acceptance Criteria (Standard/Requirement) | Reported Device Performance (K-Pack II Needle) |
|---|---|
| Intended Use Equivalence | Both the K-Pack II Needle and the predicate Terumo Disposable Hypodermic Needle are sterile medical devices for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. |
| Design and Materials Equivalence | Both needles are made of a stainless steel needle tube (sharpened at one end with the same geometry) and a female luer connector (6% luer) made of polypropylene. Components (Cannula, Hub, Glue, Lubricant) are identical to the predicate (Stainless steel, Polypropylene, Epoxy glue, Silicone, respectively). |
| Performance Standard (EN ISO 7864:1995) | Complies with requirements of EN ISO 7864 (1995) Sterile Hypodermic Needles for single use ( = ISO 7864:1993), with the following noted exception/clarification: - Section 9.1 Conical fitting: Does not completely match ISO 594-2 specifications for locking fittings, however, when tested according to ISO 594-2, no liquid or air leakage is observed. - Section 13.2 Patency of lumen: No specifications given for a 25G ultra-thin wall needle, so comparison with a reference for this property was not possible for the 25G K-Pack Needle. |
| Sterility Assurance Level (SAL) | Sterility is assured by a validated sterilization method (Ethylene Oxide) in accordance with EN 550, achieving a SAL of 10^-6, as required by EN 556. Routine checks include physical parameter recordings and sterility control on biological indicators. |
| Biocompatibility | Tested in accordance with FDA General Program Memorandum # G95-1 (ISO 10993 Part 1) for External Communicating Devices, Blood Path Indirect, Limited Duration of Contact (< 24 hours). Results found blood contacting materials to be compatible. |
| LAL Test | Performed on production samples of each lot number. (Implies compliance with endotoxin limits, though specific limits are not stated). |
| Manufacturing Control | Manufacturing control test methods include controls on functional performance. (Implies meeting internal functional requirements). |
| Expiration Dating | Established to be 60 months or five (5) years. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a "test set" in the context of clinical trials. Compliance with standards and material testing would have involved specific sample sizes per test, but these are not detailed in the summary.
- Data Provenance: The document is primarily a regulatory submission from TERUMO EUROPE N.V. based in Belgium. The testing cited (EN ISO standards, biocompatibility testing) would have been conducted or overseen by the manufacturer or a contracted lab. The data is retrospective in the sense that it supports the premarket notification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This section is not applicable as the device is a simple hypodermic needle and the evaluation is based on compliance with engineering and material standards, not interpretive tasks requiring expert consensus on a "ground truth" (e.g., image interpretation).
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as above.
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 section is not applicable. The device is a physical hypodermic needle, not an AI-driven system or a diagnostic tool that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical hypodermic needle, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by:
- International Standards: EN ISO 7864, ISO 594-2, EN 550, EN 556, ISO 10993.
- Material Specifications: Chemical composition and physical properties of the materials (stainless steel, polypropylene, epoxy glue, silicone).
- Functional Testing: "Functional performance" controls.
- Biocompatibility Testing: Evaluating biological response to the materials.
8. The Sample Size for the Training Set
This section is not applicable. As a physical medical device, there is no "training set" in the AI/software sense. The design and manufacturing processes are refined through engineering, testing, and quality control, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no "training set" for this type of device.
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510(k) Summary as required by 807.95 (c) II. SUMMARY AND CERTIFICATION Summary of Safety & Effectiveness Information
- II.1. Proprietary Device Name
K-Pack II Needle
II.2. Classification Name
Hypodermic Single Lumen Needle
II.3. Reason for submission
New Device
- II.4. Intended Use
The 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.
II.5. Description
The 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 male connector (nozzle) of a piston syringe or an intravascular administration set.
II.6. Substantial Equivalence
The K-Pack II Needles submitted in this 510k file are substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared Terumo Disposable Hypodermic Needle which is the subject of K771203. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.
| INTENDED USE: | Both needles being Hypodermic Single Lumen Needles aresterile medical devices for single use, intended to inject fluidsinto, or withdraw fluids from, parts of the body below thesurface of the skin. |
|---|---|
| DESIGN AND MATERIALS: | Both needles are made of a stainless steel needle tube that is |
DESIGN AND MATERIALS: Both needles are made of a stainless steel needle tube that is sharpened at one end (both types of needles having exactly the same geometry) and at the other end joined to a female connector (6% luer) made of polypropylene. The difference between both needles is the packaging style and the sterilization method.
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K-Pack II needles are packed in a hard pack (cap - case) and sterilised by ethylene oxide while the Terumo Needles are packed in a blister pack (film - film) and sterilized by gamma-irradiation.
The differences in packaging style and sterilization method do not affect the substantial equivalence of the devices.
Proposed:
| PRODUCTCODE | NEEDLEGAUGE | NEEDLELENGTH | NEEDLEBEVEL |
|---|---|---|---|
| KN-2325RB | 23 | 1" | regular |
| KN-2525RB | 25 | 1" | regular |
| KN-2516RB04 | 25 | 5/8" | regular |
Predicate:
| PRODUCTCODE | NEEDLEGAUGE | NEEDLELENGTH | NEEDLEBEVEL |
|---|---|---|---|
| 3NN*2325R | 23 | 1" | regular |
| 3NN*2525R | 25 | 1" | regular |
| 3NN*2516R | 25 | 5/8" | regular |
Materials:
| COMPONENT | PROPOSED | PREDICATE |
|---|---|---|
| Cannula | Stainless steel | Stainless steel |
| Hub | Polypropylene | Polypropylene |
| Glue | Epoxy glue | Epoxy glue |
| Lubricant | Silicone | Silicone |
PRINCIPLES OF OPERATION/ TECHNOLOGY STATEMENT
The K-Pack II Needle and the Terumo Disposable Hypodermic Needle are both operated manually. .
COMPARISON TESTING OF The K-Pack II Needles comply with the requirements specified in EN ISO 7864 (1995) Sterile Hypodermic K-PACK NEEDLES WITH Needles for single use (= ISO 7864: 1993) with exception EN ISO 7864 of Section 9.1 Conical fitting: if the hub has a locking fitting, it shall be in accordance with ISO 594-2. The K-Pack II Needles are not completely matching the specification of ISO 594-2, however when tested in accordance to ISO 594-2, no liquid or air leakage is observed.
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Comment:
Section 13.2 Patency of lumen: no specifications are given for a 25G having an ultra thin wall needle. Consequently the 25G K-Pack Needle having an ultra thin wall needle could not be compared with a reference for this property.
II.8. Additional Safety Information
The sterility of the K-Pack II Needles 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" to a sterility assurance level (SAL) of 10 ° as required by EN 556: "Sterilization of Medical Devices: Requirements for medical devices to be labelled STERILE."
In routine the sterilization of each lot is assured by checking the recordings of the physical parameters and by performing a sterility control on biological indicators placed at different places in the sterilization tank and sterilized simultaneously with the products.
The biocompatibility of the K-Pack II Needles is tested in accordance with the tests recommended in the FDA General Program Memorandum # G95-1 (5/1/95): Use of International Standard ISO 10993 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing:'' [External Communicating Devices, Blood Path Indirect, Limited Duration of Contact (L 24 hours)].
The blood contacting materials were found to be compatible.
A LAL test is performed on production samples of each lot number.
The manufacturing control test methods include controls on functional performance.
The expiration dating for the K-Pack II Needles has been established to be 60 months or five (5) years.
II.9. Conclusion
The K-Pack II Needles submitted in this 510k file are substantially equivalent in intended use, design, specifications, technology/principles of operations, materials and performance to the cleared Terumo Disposable Hypodermic Needle which is subject of K771203. Differences between the devices cited in this section do not raise any new issues of safety on effectiveness.
II.10. Preparation info
| Date prepared: | 03/12/1998 |
|---|---|
| Prepared by: | M.J. Aerts - Manager Regulatory Affairs |
| Prepared for: | TERUMO EUROPE N.V.Researchpark Zone 2, Interleuvenlaan 40, 3001 LeuvenBELGIUMTel.: 0032 / 16 / 381 353 |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 4 1999
Mrs. M.J. Aerts Manager Requlatory Affairs TERUMO EUROPE NV Researchpark Zone 2 Haasrode Interleuvenlaan 40 B-3001 Leuven - Belgie (Belgium)
K984576 Re: K-Pack II (Hypodermic Needle) 23G X 1, Model Trade Name: KN-2325RB II Regulatory Class: Product Code: FMI Dated: May 11, 1999 Received: May 14, 1999
Dear Mrs. Aerts:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mrs. Aerts
Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page ( of l
·510(k) Number (if known): _K98 4574
Device Name: K-PACK II NEEDLE (= Hypodermic Needle)
Indications For Usc:
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The K-Pack II Needle being a Hypodermic Single Lumen Needle is a sterile medical device me wrack in wedded boling a lifest fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patrice Cusente
(Division Sien Division of De and General Ha 5 1 0(k) Numbe
Frescription Use U (Per 21 CFR 801.109) OR
Over-The-Counter Use ___________
(Optional Formal 1-2-96)
§ 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).