(62 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 Guam Needle - is a sterile, single use only 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 document for K980471 pertains to the clearance of an acupuncture needle (KHT Guam Needle). The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical performance studies with acceptance criteria in the way a novel medical device or AI-driven diagnostic would require.
Therefore, many of the requested elements regarding acceptance criteria, study design, expert involvement, and ground truth are not applicable in this context. The 510(k) process for this type of device relies on established safety and efficacy profiles of similar legally marketed devices.
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device: The KHT Guam Needle is substantially equivalent to a legally marketed predicate device (Seirin Brand Acupuncture Needle, K963769, and pre-amendment devices) in terms of design, materials, sterility, biocompatibility, and intended use. | The KHT Guam Needle is a sterile, single-use only acupuncture needle. The submission states that its "design, material used, sterility and biocompatibility... meet the general specifications and criteria for a single use acupuncture needle and is effective for the practice of acupuncture." The FDA's clearance letter confirms the substantial equivalence finding. |
| Safety: No serious or life-threatening accidents involving acupuncture needles known over 30 years of use. | The device is intended for the same use as acupuncture needles that have been used for over 30 years, during which no serious or life-threatening accidents were reported for the general category. The KHT_Guam Needle offers "greater safety" as it is sterilized and single-use, unlike some pre-amendment devices. |
| Effectiveness: Effective for the practice of acupuncture. | The submission states the device "is effective for the practice of acupuncture." This is implicitly accepted by the FDA's substantial equivalence finding, as the predicate devices were considered effective for this purpose. |
| Sterility: Device must be sterile. | The KHT Guam Needle is described as a "sterile, single use only acupuncture needle." (Implied by current market standards and predicate). |
| Biocompatibility: Device materials must be biocompatible. | The submission states that the "biocompatibility of this acupuncture needle meet the general specifications and criteria" for a single-use acupuncture needle. |
| Single Use: Device must be for single use only. | The KHT Guam Needle is described as a "single use only acupuncture needle." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for this 510(k) submission. There was no "test set" in the sense of a clinical performance study with a specific sample size. The substantial equivalence argument relies on comparison to existing devices and general knowledge of acupuncture needle safety.
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. No ground truth was established by experts for a specific test set. The regulatory determination of "substantial equivalence" is made by the FDA based on the provided documentation and comparison to predicate devices, not on expert consensus on a new test set's ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no test set or adjudication method as typically understood in performance studies.
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
- No, this is not applicable. The device is an acupuncture needle, not an AI-driven diagnostic or image analysis tool. Therefore, MRMC studies and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, this is not applicable. The device is an acupuncture needle, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the conventional sense of a clinical study. The "ground truth" for this 510(k) process is the established safety and effectiveness of the predicate devices and the general understanding of acupuncture needles as a class of device that has been in safe use for an extended period. The FDA's determination of substantial equivalence serves as the regulatory "truth."
8. The sample size for the training set
- Not applicable. There was no "training set" for an algorithm.
9. How the ground truth for the training set was established
- Not applicable. There was no "training set" or algorithm.
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APR - 9 1998
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):
FOA/CDRH/ODE/DMC
6 FEB 98 10 54
RECEWED
| 510(k) SUMMARY | |
|---|---|
| As Required by 21 CFR 807.92(c) | |
| Trade Name: | KHT Guam Needle |
| Common Name: | Acupuncture Needles |
| Classification Name: | Class II, Single use acupuncture needle |
| Legally Marketed Device to Which We Are Claiming Equivalence: | |
| Seirin Brand Acupuncture Needle | |
| 510(k) Document Number: K963769 |
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 Guam Needle - is a sterile, single use only 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 Guam Needle meets the criteria for 510(k) acceptance. The KHT Guam Needle is equivalent to acupuncture needles which were in commercial distribution prior to May 28, 1976. Also, the KHT Guam Needle is equivalent to other single use acupuncture needles which are currently being sold through interstate commerce.
Jin Hae Lew, Director
1-22-98
Date
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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 features a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circle's perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
American Institute of Koryo Hand Therapy, Incorporated .C/O Mr. George Su APR - 9 1998 Requlatory Consultant Crosslinks International 17870 Castleton Street, Suite 265 Industry, California 91748
Re : K980471 KHT Guam Needle, Acupuncture Needles Trade Name: Requlatory Class: II Product Code: MOX Dated: January 22, 1998 Received: February 6, 1998
Dear Mr. Su:
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. ਜੋ 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Su
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 regulation (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 qeneral 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 ) _
KHT Guam Needle, Acupuncture Needle Device Name:
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 )
Patruca Cassesite
Division of Oil & Gas
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _
OR
Prescription Use
Over-The-Counter Use __
( Optional Format 1-2-96 )
Page 13 of 19
§ 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.