COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS by TEVA MEDICAL, LTD.

The provided text is a 510(k) clearance letter from the FDA for a device called "Copaxone (Glatiramer Acetate for Injection) EZ-Ject from Shared Solutions." This letter primarily discusses the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.

However, the document does NOT contain information regarding:

Acceptance criteria: Specific performance metrics or thresholds the device needed to meet.
A study proving the device meets acceptance criteria: There is no description of any clinical trial, bench test, or other study.
Reported device performance: No data on accuracy, precision, reliability, or any other performance metric is provided.
Sample size for test set or training set.
Data provenance.
Number or qualifications of experts.
Adjudication method.
MRMC comparative effectiveness study or human reader improvement.
Standalone algorithm performance study.
Type of ground truth used.
How ground truth was established for training set.

The letter is a regulatory document confirming substantial equivalence, not a summary of a performance study. It states the "Indications for Use" for the device, which is "Subcutaneous injection of Copaxone®." This is a functional description, not a performance criterion.

Therefore,Based on the provided text, I cannot describe the acceptance criteria or the study that proves the device meets the acceptance criteria as this information is not present in the document. The document is a 510(k) clearance letter from the FDA, which confirms the device's substantial equivalence to a predicate device but does not detail the technical performance criteria or the studies conducted to establish them.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES . . . .

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael M. Landa, Esq. Teva Medical, Ltd. C/O Teva Pharmaceuticals USA 1510 Delp Drive Kulpsville, Pennsylvania 19443

DEC 1 9 1997

Re : K974171 Copaxone (Glatiramer Acetate for Injection) Trade Name: EZ-Ject from Shared Solutions Requlatory Class: II Product Code: KZH Dated: October 31, 1997 Received: November 5, 1997

Dear Mr. Landa:

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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labelinq, and prohibitions aqainst 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Landa

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 requlations.

This letter will allow you to beqin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally marketed predicate device results in a classification for vour 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 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

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Appendix 2 Indications for Use Statement

Page 1 of 1

катай ----------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number (if known):

Device Name: Copaxone (glatiramer for injection) EZ-Ject from Shared Solutions

Indications for use:

Subcutaneous injection of Copaxone®.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number	K974171

Prescription Use		OR	Over-The-Counter Use
(Per 21 C.F.R. 801.109)			(Optional Format 1-2-96)

Regulation Number and Section

§ 880.6920 Syringe needle introducer.

(a)
Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.(b)
Classification. Class II (performance standards).