(24 days)
The Applied Laparoscopic Monopolar Scissors is indicated for use in patients undergoing general, gynecologic and urologic endoscopic procedures for mobilization and transection of tissue.
The Applied Laparoscopic Disposable Monopolar Scissors consists of a ratcheting handle attached to an insulated shaft with scissor blades. The handle includes male cautery connector to be utilized for monopolar cautery when attached to standard monopolar cautery cables and their generators. The scissor blade length is 17.4mm and the blade opening is 5.59mm and will be available in working lengths of 32cm, and 45cm. The device is to be supplied sterile in single unit pouches.
This document describes the premarket notification (510(k)) for the Applied Laparoscopic Disposable Monopolar Scissors. The study conducted was a substantial equivalence comparison to a predicate device, not a multi-reader, multi-case comparative effectiveness study or a standalone algorithm performance study. Therefore, some requested information regarding AI-specific studies (e.g., effect size of human readers with AI, training set details, and ground truth establishment for training) is not applicable to this submission.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Design Input Requirements) | Reported Device Performance (functional characteristics) |
|---|---|
| Biocompatibility | Compliance with ISO 10993 |
| Sterility Assurance Level | 10⁻⁶ (validated using AAMI FDS-1 TIR 27 2001 Radiation sterilization - Substantiation of 25 kGy as sterilization dose - Method VDMax) |
| Dielectric Withstand (per ANSI/AAMI HF-18: 2001) | Met acceptance criteria during bench testing |
| Cutting Functionality | Met acceptance criteria during bench testing |
| Monopolar Functionality | Met acceptance criteria during bench testing |
| Dimensional Compatibility (with specified ranges for blade length, opening, and working lengths) | Met acceptance criteria during dimensional comparison |
| Substantial Equivalence to predicate device (functional characteristics) | Demonstrated through design analysis, comparisons, and bench testing to the Applied Laparoscopic Monopolar Scissor (K040295) |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes bench testing and design analysis for various functional characteristics and dimensional comparisons. It does not specify a "test set" in terms of patient data or clinical cases. The testing was conducted on the physical device itself. Therefore, information on sample size for a "test set" in the context of clinical data or data provenance (country of origin, retrospective/prospective) is not applicable or provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. The study involved engineering and performance testing of a medical device, not the interpretation of medical images or clinical data requiring expert reviewers for ground truth.
4. Adjudication Method for the Test Set:
Not applicable. As described above, this study did not involve expert review or adjudication of a test set of medical cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
No, an MRMC comparative effectiveness study was not done. This 510(k) submission is for a surgical instrument, not an AI-powered diagnostic or assistive technology. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone algorithm performance study was not done. This submission pertains to a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance was established through engineering specifications, regulatory standards (e.g., ISO 10993, ANSI/AAMI HF-18, AAMI FDS-1 TIR 27 2001), and direct functional testing against these predefined criteria, as well as comparison to the predicate device's established performance. Metrics such as dielectric withstand, cutting force, monopolar energy delivery, and dimensional accuracy served as the "ground truth" for evaluating the device.
8. The Sample Size for the Training Set:
Not applicable. This submission is for a physical medical device and does not involve an AI algorithm with a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no AI algorithm with a training set, the concept of establishing ground truth for a training set is not relevant to this submission.
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510(k) SUMMARY
| 510(k) NUMBER: | PENDING K062169 |
|---|---|
| SUBMITTED BY: | Applied Medical Resources Corporation22872 Avenida EmpresaRancho Santa Margarita, CA-92688(949) 713-8327cblake@appliedmedical.comFax: (949) 713-8205 |
| CONTACT PERSON: | Cheryl BlakeVice President Regulatory Affairs |
| DATE OF PREPARATION: | July 7, 2006 |
| NAME OF DEVICE: | Laparoscopic Disposable Monopolar Scissors |
| COMMON NAME: | Laparoscopic Scissors |
| CLASSIFICATION NAME: | Gynecologic laparoscope and accessories(Regulation Number 21CFR 884.1720)Product Code HET |
| TRADE NAME: | Applied Laparoscopic Disposable MonopolarScissors |
| PREDICATE DEVICE: | Applied Laparoscopic Monopolar Scissor(K040295) |
The Applied Laparoscopic Monopolar Scissors is intended for use INTENDED USE: in general and gynecologic endoscopic procedures for mobilization and transection of tissue.
TECHNOLOGY CHARACTERISTICS: The Applied Laparoscopic Disposable Monopolar Scissor
SUMMARY STATEMENT:
The Applied Laparoscopic Disposable Monopolar Scissors is designed to for a variety of general and gynecologic endoscopic procedures for mobilization and transection of tissue. The Applied Laparoscopic Disposable Monopolar Scissors consists of a ratcheting handle attached to an insulated shaft with scissor blades.
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The handle includes male cautery connector to be utilized for monopolar cautery when attached to standard monopolar cautery cables and their generators.
The scissor blade length is 17.4mm and the blade opening is 5.59mm and will be available in working lengths of 32cm, and 45cm. The device is to be supplied sterile in single unit pouches.
The device is in compliance with ISO 10993 for Biocompatibility. The Applied Laparoscopic Disposable Monopolar Scissors will be sterilized using a Cobalt 60 Gamma Radiation; AAMI/ISO Guideline for Radiation Sterilization will be utilized to provide a Sterility Assurance Level of 10°. The method of validation is AAMI FDS-1 TIR 27 2001 Radiation sterilization - Substantiation of 25 kGy as sterilization dose - Method VDMax. The validated does is 25 to 40 kGy.
The device is identical in materials and characteristics of the predicate device, with the exception of the insulated shaft. The predicate device utilized thermoplastic shrink tubing and the new device utilizes thermoplastic extruded tubing. The energy source, Monopolar Electrosurgical Energy, is the same energy type as used for the predicate device.
Design Analysis and comparisons, as well as bench testing, has been conducted to confirm the functional characteristics are substantially equivalent to the predicate device cited, and that the design output put mects the design input requirements.
The performance of the Applicd Laparoscopic Disposable Monopolar Scissors is compared to the performance of the Applied Medical Laparoscopic Monopolar Scissors, which is cleared to market under premarket notification, K040295. Functional Performance Testing conducted includes the performance of the following tests:
- a) Dielectric Withstand Testing per ANSI/AAMI HF-18: 2001
- b) Cutting Functionality Test
- c) Monopolar Functionality Test
- d) Dimensional Comparison
Conclusion: Based upon the technical information, intended use, and performance information provided in the pre-market notification, the Applied Laparoscopic Disposable Monopolar Scissors and the Applied Laparoscopic Monopolar Scissor (K040295) has shown to be substantially equivalent, and the design control process confirm the that design outputs mects the design input requirements.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three curved lines representing its body and wings.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG 2 4 2006
Applied Medical Resources Corporation % Mr. Jeffrey D. Rongero Senior Project Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Rd. MELVILLE NY 11747
Re: K062169
Trade/Device Name: Applied Laparoscopic Disposable Monopolar Scissors Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: HET Dated: August 11, 2006 Received: August 14, 2006
Dear Mr. Rongero:
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.
Image /page/2/Picture/10 description: The image is a black and white circular logo. The logo has the text "1906-2006" at the top, followed by the letters "FDA" in a stylized font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are at the bottom of the logo.
Protecting and Promoting Public Health
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Page 2 -
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) rms leter 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 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 under the Act from the Division of Small Manufacturers, International and Consumer Assistance at 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.Bogdon
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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Indications for Use
510(k) Number (if known): KO6 2/69
Applied Laparoscopic Disposable Monopolar Scissors __ Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use:
Indications for Use: The Applied Laparoscopic Monopolar Scissors is indicated for use in patients undergoing general, gynecologic and urologic endoscopic procedures for mobilization and transection of tissue.
Prescription Use __ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | 4062169 |
§ 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.