(42 days)
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
The subject of this 510(k) Notification - the KHT Seoam Needle - is a sterile, single use only hand acupuncture needle. The design, material used, sterility and biocompatibility of this acupuncture needle meet the general specifications and criteria for an single use acupuncture needle and is effective for the practice of acupuncture.
The provided 510(k) summary for the KHT Seoam Needle does not contain the detailed study information typically associated with acceptance criteria tables, sample sizes, expert involvement, or multi-reader multi-case studies as requested in the prompt. This submission relies on substantial equivalence to a predicate device rather than presenting a performance study with specific quantitative acceptance criteria.
Therefore, many of the requested fields cannot be filled based on the provided text.
Here's a breakdown of what can be answered and what cannot:
1. A table of acceptance criteria and the reported device performance
The submission states that the device "meet the general specifications and criteria for a single-use acupuncture needle and is effective for the practice of acupuncture." However, it does not provide specific, quantitative acceptance criteria (e.g., tensile strength, penetration force, sterility pass rates) or detailed performance data against such criteria. The primary "performance" stated is that it is "effective for the practice of acupuncture," which is a general claim rather than a measured performance metric.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided. The submission focuses on design, material, sterility, and biocompatibility, but no specific test set sample sizes or data provenance for performance testing are mentioned.
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)
Not applicable. There's no indication of a test set requiring expert ground truth establishment in the context of this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 is a medical device (acupuncture needle), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable in the typical sense of diagnostic ground truth. The "ground truth" for an acupuncture needle would pertain to its physical and functional properties (e.g., sterility, biocompatibility, sharpness, break resistance for effective and safe use).
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable.
Summary based on the provided text:
The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, particularly in terms of design, materials, sterility, and biocompatibility, rather than presenting a detailed performance study against specific, quantitative acceptance criteria.
KHT Seoam Needle Substantial Equivalence Claim:
- Legally Marketed Predicate Device: CW-Disposable Acupuncture Needle (510(k) Document Number: K962419) and acupuncture needles in commercial distribution prior to May 28, 1976.
- Key Equivalence Claims:
- Sterile
- Single-use only
- Hand acupuncture needle
- Design, material used, sterility, and biocompatibility meet general specifications and criteria for a single-use acupuncture needle.
- Effective for the practice of acupuncture.
The FDA's letter confirms that the device is "substantially equivalent" to predicate devices for the stated indications for use, without requiring explicit, quantitative performance data beyond the general claims of compliance with specifications and effectiveness for its intended purpose.
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American Institute of Koryo Hand Therapy, Inc.
3435 Wilshire Blvd., Suite 690, Los Angeles, CA 90010 Tel: (213) 380-5878 Fax: (213) 380-5876
Premarket Notification (510(k) Number):
JAN 1 3 1998
10(k) SUMMARY As Required by 21 CFR 807.92(c)
| Trade Name: | KHT Seoam Needle |
|---|---|
| Common Name: | Hand Acupuncture Needles |
| Classification Name: | Class II, Single use acupuncture needles |
Legally Marketed Device to Which We Are Claiming Equivalence: CW-Disposable Acupuncture Needle 510(k) Document Number: K962419
Acupuncture needles are defined as prescription devices intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
Acupuncture needles have been used for the general practice of acupuncture in the United States for over 30 years. Since that time, we are not aware of any serious or life threatening accidents involving acupuncture needles.
Acupuncture needles which were sold through commercial interstate distribution prior to May 28, 1976 were non-sterile, reusable acupuncture needles. Acupuncture needles which are currently being marketed through interstate distribution (i.e., 1997) offer greater safety since they are sterilzed, single use only acupuncture needles.
The subject of this 510(k) Notification - the KHT Seoam Needle - is a sterile, single use only hand acupuncture needle. The design, material used, sterility and biocompatibility of this acupuncture needle meet the general specifications and criteria for an single use acupuncture needle and is effective for the practice of acupuncture.
In conclusion, based on the information provided with this 510(k) Notification, the KHT Seoam Needle meets the criteria for 510(k) acceptance. The KHT Seoam Needle is equivalent to acupuncture needles which were in commercial distribution prior to May 28, 1976. Also, the KHT Seoam Needle is equivalent to other single use acupuncture needles which are currently being sold through interstate commerce.
lin Hao Law, Director
10-25-92
Date
Jin Hae Lew, Director
Page 5 of 12
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a symbol that appears to be three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 1998
Mr. Jin Hae Lew Director American Institute of Koryo Hand Therapy, Incorporated C/O Crosslink International 1800 Century Park East, Suite 600 Los Angeles, California 90067
K974527 Re: KHT Seoam Needle, Hand Acupuncture Needle Trade Name: II Requlatory Class: Product Code: MOX September 29, 1997 Dated: December 2, 1997 Received:
Dear Mr. Lew:
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, qood 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 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 Drug 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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Lew
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 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 diaqnostic 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
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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Indications For Use
| 510(k) Number (if known ) | K974527 |
|---|---|
| Device Name: | KHT SEOAM HAND ACUPUNCTURE NEEDLES |
Indications For Use:
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation ( ODE )
Patricia Cusack
(Division Sign-Off Division of De and General Ho E. O(k) Number
Prescription Use __
OR
Over-The-Counter Use _
( Optional Format 1-2-96 )
§ 880.5580 Acupuncture needle.
(a)
Identification. An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.(b)
Classification. Class II (special controls). The device, when it is an acupuncture point locator or a single use acupuncture needle, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. Acupuncture needles must comply with the following special controls:(1) Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109,
(2) Device material biocompatibility, and
(3) Device sterility.