(234 days)
Like the Predicate device, Storz 26033, the Baho Autoclavable Laparoscope is inicated for use in the visual examination of body cavities, hollow organs and canals, and using additional accessories, to perform various diagnostic and therapeutic procedures.
Baho Autoclavable Laparoscope
The provided text is related to an FDA 510(k) clearance for a medical device called the "BAHO Autoclavable Laparoscope." It states that the device is "substantially equivalent" to a legally marketed predicate device (Storz 26033). However, it does not contain specific information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The letter explicitly states: "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 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)."
Since this is a substantial equivalence determination based on comparison to a predicate device, a detailed separate study to establish new acceptance criteria and prove device performance in the way described in your request (e.g., with specific performance metrics, sample sizes, expert adjudication, or AI components) is typically not required or presented in such a clearance letter.
Therefore, I cannot provide the requested information. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts.
- Adjudication method for a test set.
- Details of a multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes of human readers with/without AI.
- Standalone performance studies (as the device is a laparoscope, not an AI algorithm).
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
The 510(k) process for a device like a laparoscope primarily focuses on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or that any differences do not raise new questions of safety or effectiveness. The included "Indications for Use" section further clarifies this equivalence, stating: "Like the Predicate device, Storz 26033, the Baho Autoclavable Laparoscope is indicated for use in the visual examination of body cavities, hollow organs and canals, and using additional accessories, to perform various diagnostic and therapeutic procedures."
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FFB 1 8 1999
Mr. George N. Hallack MicroOptix International., LLC 310 Main Street Suite LL-D East Haven, CT 06512
Re: K982276
BAHO Autoclavable Laparoscope Dated: November 14, 1998 Received: November 20, 1998 Regulatory Class: II 21 CFR 884.1720/Procode: 85 HET
Dear Mr. Hallack:
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 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions, Failure to comply with the GMP regult in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of 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) 594-4613. 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/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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MICROOPTIX INTERNATIONAL, LLC
The Endoscope Repair People ----
Page one of one
INDICATIONS FOR USE
- Submitter: Microptix International, LLC. 310 Main Street East Haven, CT 06512
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- 510(k) Number: K982276
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- Device Name: Baho Autoclavable Laparoscope
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- Indication for use: Like the Predicate device, Storz 26033, the Baho Autoclavable Laparoscope is inicated for use in the visual examination of body cavities, hollow organs and canals, and using additional accessories, to perform various diagnostic and therapeutic procedures.
(Please Do Not Write Below This Line - Continue On Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
(Division Sign-Off)
Over-the-counter (Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K982276/5001
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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.