Bioceptive Suction Cervical Retractor by Bioceptive Inc.

This is a 510(k) clearance letter for a medical device called the Bioceptive Suction Cervical Retractor. This type of document generally does not include detailed information about acceptance criteria and performance studies in the way you've requested for an AI/CAD device.

Here's why and what can be extracted:

Device Type: The Bioceptive Suction Cervical Retractor is a manual surgical instrument. It's not an AI/CAD system or a diagnostic device that typically relies on specific metrics like sensitivity, specificity, or AUC as primary acceptance criteria.
510(k) Process: The 510(k) pathway demonstrates "substantial equivalence" to a legally marketed predicate device, not necessarily superior performance against a rigid set of quantitative criteria in the same way an AI device might. The focus is on ensuring the new device is as safe and effective as existing legally marketed devices.
Content of the Letter: This letter confirms the FDA's decision regarding substantial equivalence based on a premarket notification. It doesn't contain the actual study data or detailed acceptance criteria for the device's functional performance beyond typical safety and efficacy considerations for a manual surgical tool.

Therefore, for this specific document and device, I cannot provide the complete information you requested. However, I can infer what would typically be relevant for such a device and what might have been part of the underlying submission if it were an AI device.

Information Extracted/Inferred (with significant limitations due to device type):

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: For a manual surgical instrument, acceptance criteria generally relate to:
  - Biocompatibility: The materials used must be safe for contact with human tissue.
  - Sterilization: The device must be able to be effectively sterilized.
  - Mechanical Strength/Durability: The device must withstand expected forces during use without breaking or failing.
  - Functional Performance (non-AI): The device must effectively "snare, grasp, hold and manipulate cervical tissue" as intended. This is typically demonstrated through bench testing, simulated use, and potentially animal or cadaver studies, but not with typical AI metrics.
  - Safety: No increased risk of harm compared to predicate devices.
- Reported Device Performance: The letter indicates the device is "substantially equivalent." This implies that the performance in the areas listed above was deemed comparable to existing devices. Specific quantitative metrics like sensitivity or specificity are not applicable or provided here.
Sample size used for the test set and the data provenance: Not applicable/Provided. For a manual surgical device, "test set" would refer to the samples used for mechanical testing, biocompatibility testing, or in-vitro/ex-vivo studies. This information is not in the clearance letter.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Provided. Ground truth for a manual instrument's performance is typically established by engineering tests and clinical evaluation by surgeons, rather than expert consensus on diagnostic interpretations.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Provided.
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 not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a manual device, ground truth would relate to its physical and mechanical properties, sterility, and performance in achieving its stated function (e.g., successful grasping of tissue without damage). This is typically established through engineering standards, material testing, and surgical observation (if clinical studies were part of the submission).
The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory clearance letter for a manual medical instrument. It does not contain the detailed performance data or study specifics that would be present for an AI-powered diagnostic device, which is what your questions seem to anticipate.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with outstretched arms, resembling an eagle or bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 19, 2014

Bioceptive Inc. Stewart Davis, M.D. CEO And President New Orleans BioInnovation Center, 1441 Canal Street, Suite 228 New Orleans, Louisiana 70112

Re: K142204 Trade/Device Name: Bioceptive Suction Cervical Retractor Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: Class II Product Code: HDC Dated: August 1, 2014 Received: August 11, 2014

Dear Stewart Davis, M.D.,

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for Benjamin Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142204

Device Name Bioceptive Suction Cervical Retractor

Indications for Use (Describe)

The Bioceptive Suction Cervical Retractor is indicated to snare, grasp, hold and manipulate cervical tissue.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Regulation Number and Section

§ 884.4530 Obstetric-gynecologic specialized manual instrument.

(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.