(183 days)
This device is restricted to use by authorized expert personnel/physicians. The WISAP POWER-DRIVE is a laparoscopic accessory to be used in connection with the SEMM-Set. It allows cutting of tissue cylinders out of myoma and uterion. It allows cutting of Cissue cyrinkers out intermittent manual rocation. rotation of the motor drive or additional interest manual rocation. The POWER-DRIVE may only be used for horizontal morcellation.
The WISAP POWER-DRIVE is a laparoscopic accessory to be used in connection with the SEMM-Set. It allows cutting of tissue cylinders out of myoma and uterion. It allows cutting of Cissue cyrinkers out intermittent manual rocation. rotation of the motor drive or additional interest manual rocation. The POWER-DRIVE may only be used for horizontal morcellation.
This is a 510(k) premarket notification for a medical device (WISAP Power-Drive, Model #7688PD/7688PD1), which is a regulatory submission to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of document does not typically include detailed clinical study data or acceptance criteria in the way a clinical trial report or a PMA (Premarket Approval) submission would.
The document states that the FDA has reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices. This determination is based on the information provided by the manufacturer, which would typically include technical specifications, performance testing (bench testing), and sometimes a comparison to the predicate device's features.
Therefore, most of the information requested in your prompt regarding acceptance criteria and studies proving the device meets them will not be explicitly present in this particular FDA letter or the accompanying "Indications for Use" statement. This letter is the FDA's response to the 510(k) application, not the application itself.
However, based on the nature of a 510(k) and the information provided, we can infer some details and state what is not present:
Inferred or Not Applicable Information:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in this document. For a 510(k), acceptance criteria would typically relate to demonstrating performance consistent with the predicate device, often through bench testing (e.g., cutting efficacy, torque, durability, safety features).
- Reported Device Performance: Not detailed in this document. The manufacturer would have submitted this in their 510(k) application (e.g., results of bench tests demonstrating appropriate cutting capacity for tissue cylinders, safety features, and mechanical performance).
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not present in these documents. Given it's a laparoscopic accessory for cutting tissue, any "test set" would likely refer to engineering or bench testing, not a patient cohort in a clinical study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable/present. This device is a surgical instrument. "Ground truth" in this context would likely be established through engineering specifications and the physical properties of cut tissue, not expert medical interpretation of images or observations.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/present. Adjudication is typically associated with clinical studies involving interpretation, not mechanical device performance.
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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:
- Definitely not applicable. This device is a surgical tool, not an AI-powered diagnostic or interpretive system. MRMC studies are for evaluating diagnostic accuracy, especially with imaging.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Definitely not applicable. This is a mechanical surgical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated. For a mechanical device, ground truth would likely involve measuring physical parameters (e.g., dimensions of cut tissue cylinders, precision of rotation, material properties) against engineering specifications and predicate device performance.
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The sample size for the training set:
- Not applicable. This device does not use machine learning or AI that would require a "training set."
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How the ground truth for the training set was established:
- Not applicable. As above.
Summary based on the provided documents:
The FDA letter indicates that the WISAP Power-Drive (Model #7688PD/7688PD1) was deemed substantially equivalent to a predicate device. This implies that the manufacturer provided sufficient evidence (likely through engineering and performance testing, and a comparison to the predicate) to satisfy the FDA that it performs as intended and is as safe and effective as the already-marketed predicate. The specific details of that evidence, including acceptance criteria and study results, are contained within the full 510(k) submission, not in this response letter or the indications for use.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 9 1999
Mr. Horst Semm President WISAP Gesellschaft fur Wissenchaft Rudolf - Diesel - Ring 20 D-82054 Sauerlach b. Munchen, Germany
Re: K982515 Power-Drive WISAP Model #7688PD/7688PD1 Dated: October 29, 1998 Received: November 2, 1998 Regulatory Class: II 21 CFR 884.1720/Procode: 85 HET
Dear Mr. Semm:
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 Requiations, 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 regulation (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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K982515 5 10(k) Number (if known):
POWER-DRIVE 7688PD/7688PD1 Device Name:
Indications For Use:
This device is restricted to use by authorized expert personnel/physicians.
The WISAP POWER-DRIVE is a laparoscopic accessory to be used in connection with the SEMM-Set.
with the Systems-Set.
It allows cutting of tissue cylinders out of myoma and uterion. It allows cutting of Cissue cyrinkers out intermittent manual rocation.
rotation of the motor drive or additional interest manual rocation. The POWER-DRIVE may only be used for horizontal morcellation.
(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
Over-The-Counter Use
(Optional Format 1-2-96)
Ehrich A. Bergman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number
§ 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.