(56 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) application - the KHT Sooji Needle - is a sterilized, 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 document is a 510(k) summary for the KHT Sooji Needle, a hand acupuncture needle. It focuses on demonstrating substantial equivalence to pre-amendment devices and currently marketed single-use acupuncture needles rather than reporting performance against specific acceptance criteria from a comprehensive study to prove detailed device performance.
Therefore, the requested information elements (1-9) about acceptance criteria, study details, and ground truth establishment are largely not applicable or extractable from this type of regulatory submission. This document highlights that the device "meets the general specifications and criteria for a single use acupuncture needle and is effective for the practice of acupuncture," but it does not present a formal study with detailed acceptance criteria and performance metrics in the format requested.
However, I can extract the following information that is available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied from 510(k) Summary) | Reported Device Performance |
|---|---|
| Sterilization | Sterilized |
| Single-use design | Single-use only |
| Biocompatibility | Biocompatibility meets general specifications |
| Material used | Material meets general specifications |
| Effectiveness for acupuncture practice | Effective for the practice of acupuncture |
| Equivalence to pre-amendment devices | Equivalent to acupuncture needles in commercial distribution prior to May 28, 1976 |
| Equivalence to currently marketed single-use acupuncture needles | Equivalent to other single-use acupuncture needles currently sold through interstate commerce |
Comment: The document doesn't define quantitative 'acceptance criteria' in the sense of specific thresholds for a study (e.g., minimum sensitivity, specificity, accuracy). Instead, it asserts that its design, material, sterility, and biocompatibility "meet the general specifications and criteria" for the device type and that it is "effective for the practice of acupuncture." The primary 'acceptance criterion' for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device.
2. Sample size used for the test set and the data provenance
- Not Applicable. The 510(k) summary provided does not describe a performance study with a distinct test set, sample size, or data provenance. The assessment is based on design, materials, and comparison to predicate devices, not on a clinical or performance trial with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No test set or ground truth establishment by experts is described in this regulatory submission.
4. Adjudication method for the test set
- Not Applicable. No test set or adjudication method is described.
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 device is a physical medical device (acupuncture needle), not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is irrelevant.
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 consensus, pathology, outcomes data, etc.)
- Not Applicable. No formal ground truth for performance evaluation is described. The "ground truth" for the 510(k) process is the established safety and effectiveness of the predicate devices to which substantial equivalence is claimed.
8. The sample size for the training set
- Not Applicable. The 510(k) summary does not describe a machine learning model or a training set.
9. How the ground truth for the training set was established
- Not Applicable. The 510(k) summary does not describe a machine learning model or a training set with established ground truth.
In summary, this 510(k) document is a regulatory submission demonstrating substantial equivalence rather than a clinical or performance study that would typically include the detailed information requested for device performance assessment.
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800JI NEEDLE
K 980469
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]:
510(k) SUMMARY As Required by 21 CFR 807.92(c)
| Trade Name: | KHT Sooji 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 sterlilized, single use only acupuncture needles.
The subject of this 510(k) application - the KHT Sooji Needle - is a sterilized, 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) application, the KHT Sooji Needle meets the criteria for 510(k) acceptance. The KHT Sooji Needle is equivalent to acupuncture needles which were in commercial distribution prior to May 28, 1976. Also, the KHT Sooji Needle is equivalent to other single use acupuncture needles which are currently being sold through interstate commerce.
Jin Hae Lew, Director
22-98 Date
Page 3 of 16
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 APR
American Institute of Koryo Hand Therapy, Incorporated C/O Mr. George Su Requlatory Consultant Crosslinks International 17870 Castleton Street, Suite 265 Industry, California 91748
Re : K980469 KHT Sooji Needle, Hand Acupuncture Needles Trade Name: Requlatory Class: II Product Code: MQX 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, Druq, 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. ਬੈ 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 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
Timo Directbr 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 Sooji Needle, Hand 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 )
Patrica Crescent
(Division Sign-Off)
(Li
- Division of Dental, Infection Copntrol, and General Hospital Devi D
c.
510(k) Number K980469
510(k. ....
Prescription Use __ OR Over-The-Counter Use __
( Optional Format 1-2-96 )
Page 11 of 16
§ 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.