(174 days)
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
Precision Press Tack / Intraderm Needles, Precision Seven Star Needles, Präzision Acupuncture Needles, Alpha Acupuncture Needles, Fine Point Acupuncture Needles, Chi Acupuncture Needles and Zen Acupuncture Needles are sterile, single use only. The design, material used, sterility and biocompatibility of this acupuncture Needles meet the general specifications and criteria for an single use acupuncture Needles and is effective for the practice of acupuncture.
This 510(k) premarket notification for acupuncture needles (K061517) is a submission for a Class II medical device, and as such, it relies on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data with acceptance criteria for device performance as would be expected for novel, high-risk devices. The notification focuses on showing that the new acupuncture needles are as safe and effective as already legally marketed acupuncture needles.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the traditional sense for this 510(k). The "acceptance criteria" here are met by demonstrating the substantial equivalence of the new devices to existing, legally marketed predicate devices. The performance is therefore implicitly accepted as being equivalent to these predicates.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Equivalence to Predicate Devices: | |
| Same intended use as predicate devices | Intended for the practice of acupuncture by qualified practitioners. |
| Similar technological characteristics (design, materials, sterility, biocompatibility) to legally marketed predicate acupuncture needles. | "The design, material used, sterility and biocompatibility of this acupuncture Needles meet the general specifications and criteria for a single use acupuncture Needles and is effective for the practice of acupuncture." |
| No new questions of safety or effectiveness are raised. | Search of Federal Consumer Information Center and U.S. Consumer Product Safety Commission websites found "no serious or life-threatening accidents involving acupuncture Needles." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. There is no specific "test set" of patient data or clinical samples mentioned for evaluating the performance of the new acupuncture needles against predefined metrics. The assessment is based on a comparison of device characteristics to predicate devices and a general safety review of existing acupuncture needles.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth, in the sense of expert-validated diagnostic classifications or outcomes, is not established for this type of submission. The safety assessment relies on publicly available incident reports for similar devices.
4. Adjudication Method for the Test Set
Not applicable. No test set of data 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 an acupuncture needle, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is an acupuncture needle and does not involve an algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for this submission is the established safety and effectiveness of legally marketed predicate acupuncture needles. This is primarily based on:
- Prior FDA 510(k) clearances: The document states, "FDA had issued 510(K)s to 47 different single use acupuncture Needless brand and them have I DA had issued 9 ro(11)3 wire in the United States since 1996." This indicates a history of regulatory acceptance for similar devices.
- Absence of reported safety issues with predicate devices: The search of consumer safety websites for adverse events ("no serious or life-threatening accidents involving acupuncture Needless") serves as a form of "negative ground truth" supporting the safety profile of the device category.
8. The Sample Size for the Training Set
Not applicable. There is no machine learning or AI component requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth establishment for it.
Summary of the Study (Demonstration of Substantial Equivalence):
The study presented in this 510(k) is not a traditional performance study with empirical data generated from the new devices. Instead, it is a demonstration of substantial equivalence. The manufacturer, Prime Herbs Co., is asserting that their various acupuncture needles (Precision Press Tack / Intraderm Needle, Precision Seven Star Needle, Präzision Acupuncture Needle, Alpha Acupuncture Needle, Fine Point Acupuncture Needle, Chi Acupuncture Needle, and Zen Acupuncture Needle) are as safe and effective as predicate devices already on the market.
The "study" or justification for this claim involves:
- Identification of Predicate Devices: While not explicitly named in the provided text, the submission implicitly references all existing 510(k)-cleared acupuncture needles as predicates.
- Comparison of Intended Use: The intended use of piercing the skin for acupuncture by qualified practitioners is identical to that of predicate devices.
- Comparison of Technological Characteristics: The submission asserts that the new needles' "design, material used, sterility and biocompatibility... meet the general specifications and criteria for a single use acupuncture Needles" and are "effective for the practice of acupuncture." This implies a comparison to the known characteristics of predicate devices.
- Safety Review of Device Category: The search of government consumer safety websites for adverse events associated with any acupuncture needles serves to support the general safety profile of this device type, thereby reinforcing the argument for the substantial equivalence of the new devices.
In essence, the "study" is a regulatory argument, not a scientific experiment with the new devices themselves. The FDA's letter confirms that they have reviewed this argument and determined the device is "substantially equivalent" to legally marketed predicate devices, thereby allowing it to proceed to market.
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October 10, 2006
PRE-MARKET NOTIFICATION 510 (K) SUMMARY
(As Required by 21 CFR 807.92)
Prime Herbs Co., 754 San Aleso Avenue Sunnyvale, CA 94085 Phone: 408-744-1077 Genevieve Hsia
NOV 2 2 2006
Device Name: Precision Press Tack / Intraderm Needle, Precision Seven Star Needle, Präzision Acupuncture Needle, Alpha Acupuncture Needle, Fine Point Acupuncture Needle, Chi Acupuncture Needle and Zen Acupuncture Needle Common Device Name: Acupuncture Needle, Signal Use Product Code: MQX Medical Specialty: General Hospital Device Class: II
Precision Press Tack / Intraderm Needles, Precision Seven Star Needles, Präzision I receision 11035 Tach / Alpha Acupuncture Needles, Fine Point Acupuncture Needles, Chi Acupuncture Needles, Inc. Zen Acupuncture Needles are defined as prescription devices intended to reapanetate rebates are tice of acupuncture by qualified practitioners of acupuncture as determined by the States.
FDA had issued 510(K)s to 47 different signal use acupuncture Needless brand and them have I DA had issued 9 ro(11)3 wire in the United States since 1996. We had searched Federal Consumer Information Center web site http://www.pueblo.gsa.gov and U.S. Consumer Product Safety Commission web site http://www.cpsc.gov and found no serious or We threatening accidents involving acupuncture Needless.
Precision Press Tack / Intraderm Needles, Precision Seven Star Needles, Präzision Acupuncture 1 (CUSTO) Fress Fack - The Point Acupuncture Needles, Chi Acupuncture Needles and Needes, Alpha Acupanedare sterile, single use only. The design, material used, sterility and hiocompatibility of this acupuncture Needles meet the general specifications and criteria for an single use acupuncture Needles and is effective for the practice of acupuncture.
In conclusion, based on the information provided with this 510(K) Notification, the Precision Press In conclusion, based on the Precision Seven Star Needles, Präzision Acupuncture Needles, Alpha Tack / Intraderin Necdles, Freehslon Soven Star Fronter Needles and Zen Acupuncture Acupunciale Necutes, I he Follo Reapanetane Press Tack / Intraderm Needles, Nectiles meet the or nerial 10. 910(1) issort Acupuncture Needles, Alpha Acupuncture Needles, Fine Point I recision Devell Star Procures Needles and Zen Acupuncture Needles are equivalent to other Acupuncture Needless which are currently being sold through interstate commerce.
Genevieve Hsia, President
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 consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Genevieve Hsia President Prime Herbs Corporation 754 San Aleso Avenue Sunnyvale, California 94085
NOV 2 2 2006
Re: K061517
Trade/Device Name: Fine Point Acupuncture Needle, Alpha Acupuncture Needle, Prazision Acupuncture Needle, Zen Acupuncture Needle, Chi Acupuncture Needle, Precision Press Tack, Precision Intradermal Needle and Seven Star Needle Regulation Number: 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MOX Dated: October 19, 2006 Received: October 19, 2006
Dear Ms. Hsia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Hsia
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Soutte y. Michael Dms.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K061517
- Device Name: Fine Point Acupuncture Needle, Alpha Acupuncture Needle, Prazision Acupuncture Needle, Zen Acupuncture Needle, Chi Acupuncture Needle, Precision Press Tack, Precision Intradermal Needle, & Seven Star Needle
- Indications For Use: To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
Prescription Use X AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suytle Y. Michem MD
Page 1 of 1
utatiology, General Hospital,
won Contol, Denial Devices
K 061517
§ 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.