(129 days)
The Fischer Cone Biopsy device is indicated for Large Loop Excision Of The Transformation Zone (LLETZ) in the diagnosis and treatment of some cervical intraepithelial neoplasias (CIN) and dysplasias.
Not Found
I apologize, but the provided text is a 510(k) clearance letter from the FDA for a medical device called the "Fischer Cone Biopsy Excisor." This type of document primarily confirms that the device is "substantially equivalent" to a legally marketed predicate device and grants permission to market it.
The document does NOT contain the following information that you requested:
- A table of acceptance criteria and reported device performance. The FDA clearance letter does not detail the specific performance metrics or acceptance criteria used in the substantial equivalence determination. It focuses on regulatory compliance rather than detailed device efficacy or safety study results in this letter.
- Sample size used for the test set and data provenance. This information would typically be found in the device's 510(k) submission, not the clearance letter.
- Number of experts used to establish the ground truth and their qualifications. Again, this level of detail about study design is not in this document.
- Adjudication method.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improvement with AI vs. without AI assistance. This device is a surgical excisor, not an AI-assisted diagnostic tool, so such a study would not be applicable.
- If a standalone performance (algorithm only) was done. Not applicable as it's not an algorithm.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
Therefore, I cannot fulfill your request for a description of the acceptance criteria and the study that proves the device meets them based on the provided text. The FDA letter only states that the device is "substantially equivalent" for its indicated uses to previously marketed devices.
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
OCT 2 0 2006
Mr. John C. Pulford Director of Operations Apple Medical Corporation 28 Lord Road, Unit 135 MARLBOROUGH MA 01752
Re: K061651
Trade/Device Name: Fischer Cone Biopsy Excisor, Models 900-150, -151, -152, -154, -155, -157 and -158 . . Regulation Number: 21 CFR §884.4120 Regulation Name: Gynecologic electrocautery and accessories Regulatory Class: II Product Code: HGI Dated: September 11, 2006 Received: September 18, 2006
Dear Mr. Pulford:
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 (Premarket Approval), 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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oting Sublic
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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. Your must comply with all the Act's requirements, including, but not limited to: registration and liasting (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 ed act 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 logal/v marketed predicate device results in a classification for your device and thus, percoits 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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 innler the Act from the Division of Small Manufacturers, International and Consumer Assistance and its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page
510(k) Number (if known):
Device Name: _Fischer Cone Biopsy Excisor
Indications for Use:
INDICATIONS FOR USE:
The Fischer Cone Biopsy device is indicated for Large Loop Excision Of The Transformation Zone (LLETZ) in the diagnosis and treatment of some cervical intraepithelial neoplasias (CIN) and dysplasias.
The intended use is the same.
Prescription Use X (Part 21 CFR 801 Subpart D) OR
Over-the -Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancyc Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K061651
§ 884.4120 Gynecologic electrocautery and accessories.
(a)
Identification. A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.(b)
Classification. Class II (performance standards).