(32 days)
The Applied Laparoscopic Monopolar Scissors is indicated for use in gynecologic and general endoscopic procedures for mobilization and transection of tissues. The device with a 5mm diameter insulated shaft has a male cautery connection on top of the handle and may be used for monopolar cautery when attached to standard cautery cables and their generators.
The Applied Laparoscopic Monopolar Scissors consists of a reusable handle and disposable insulated shaft with scissor blades. The device has a 5mm diameter disposable insulated shaft that connects to a reusable Polyenylsulfone/stainless steel handle with a male cautery connector to be utilized for monolpolar cautery when attached to standard monopolar cautery cables and their generators. The disposable shaft consists of a stainless steel outer shaft housing an actuation rod, which connects to the scissor blades and handle actuation rod. The disposable shaft is to be supplied sterile in single unit pouches. The scissor blade length is 17.4mm and the blade opening is 5.59mm and will be available in working lengths of 32cm, 38cm, and 45cm. The reusable handle is comprised of Polyphenylsulfone male and female handles with various stainless connectors and contacts. The reusable handle will be supplied non-sterile. The handle includes a 360° rotation knob for user convenience. The reusable handle is steam sterilized by the user and then connected to the sterile disposable shaft. Following use the shaft and handle are disassembled. The shaft is disposed of and the handle is cleaned and re-sterilized.
The provided text describes a 510(k) premarket notification for a medical device (Laparoscopic Monopolar Scissors), and thus focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria based on specific performance metrics.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and performance studies for the device itself.
Here's why and what information is actually available:
- Acceptance Criteria & Device Performance: The document does not define specific performance acceptance criteria (e.g., maximum force to cut, impedance levels after X uses) for the Laparoscopic Monopolar Scissors, nor does it report the device's performance against such criteria. The entire submission is based on substantial equivalence.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): Since a study comparing the device's performance against acceptance criteria is not described, none of this information is present.
What the document does provide is evidence of compliance with regulatory and manufacturing standards, and a comparison to a predicate device:
- Substantial Equivalence: The primary "study" or justification for clearance is the claim of substantial equivalence to the United States Surgical Auto Suture® Endoscopic Scissors (K903206) in intended use, design, use methodology, and similar materials.
- Biocompatibility: The device is stated to be "in compliance with ISO 10993 for Biocompatibility."
- Sterilization Validation (Shaft):
- Method: 100% Ethylene Oxide (EO) sterilization.
- Acceptance Criteria/Performance: Provides a sterility assurance level (SAL) of 10⁻⁶.
- Validation: Uses three half-cycle validation runs with biological indicators (Bacillus atrophaus var. niger with a population of 10⁶) and temperature monitors.
- Residue Levels: Complies with ANSI/AAMI/ISO 10993-7:1995 for limited exposure devices (20 mg ethylene oxide and 12 mg ethylene chlorohydrin).
- Sterilization Validation (Handle):
- Method: Steam sterilization by the user.
- Acceptance Criteria/Performance: Provides a sterility assurance level (SAL) of 10⁻⁶.
- Validation: Based on AAMI TIR No. 12 - 1994 and three sterilization cycles at one-half the exposure time using Bacillus stearothermophilus spore strips or inoculum.
- Design Controls: Manufacturer (Applied Medical) followed design control regulations per 21 CFR § 820.30 and conducted a Design Risk Assessment Profile in accordance with internal SOPs, EN 1441, ISO 9001/ISO 13485, AAMI/ISO TIR 14971, and 21 CFR § 820.30. Validation and verification activities addressed the risk profile, including methods, tests, and acceptance criteria (though these specific criteria are not detailed in the document).
In summary, while the document confirms that validation and verification activities included acceptance criteria, it does not detail those criteria or the performance results against them in a format comparable to the request for an AI/diagnostic device study.
Hypothetical Table based on the limited information that resembles acceptance criteria, if it were for a diagnostic device:
| Acceptance Criteria Category | Reported Device Performance (from text) |
|---|---|
| Sterility Assurance Level (EO sterilized shaft) | 10⁻⁶ SAL |
| Sterility Assurance Level (Steam sterilized handle) | 10⁻⁶ SAL |
| Ethylene Oxide Residue (shaft) | ≤ 20 mg (in compliance with ANSI/AAMI/ISO 10993-7:1995) |
| Ethylene Chlorohydrin Residue (shaft) | ≤ 12 mg (in compliance with ANSI/AAMI/ISO 10993-7:1995) |
| Biocompatibility | In compliance with ISO 10993 |
| Design Control Compliance | Follows 21 CFR § 820.30, EN 1441, ISO 9001/ISO 13485, AAMI/ISO TIR 14971 |
| Substantial Equivalence | Equivalent in intended use, design, use methodology, materials to K903206 |
As noted, the remaining points of your request are not applicable as this document details a 510(k) clearance based on substantial equivalence for a physical surgical tool, not an AI or diagnostic device with specific performance metrics defined by a clinical study.
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MAR 1 2 2004
Page 1 of 3
510(k) SUMMARY
| 510(k) NUMBER: | PENDING K040295 |
|---|---|
| SUBMITTED BY: | Applied Medical Resources Corporation22872 Avenida EmpresaRancho Santa Margarita, CA-92688(949) 713-8327FAX (949) 713-8205 |
| CONTACT PERSON:Programs | Cheryl BlakeDirector of Regulatory Affairs and Clinical |
| DATE OF PREPARATION: | January 15, 2004 |
| NAME OF DEVICE: | Laparoscopic Monopolar Scissors |
| CLASSIFICATION NAME: | Gynecologic laparoscope and accessories(Regulation Number 21CFR 884.1720 andaccessories). |
| TRADE NAME: | Applied Laparoscopic Monopolar Scissors |
| PREDICATE DEVICE: | United States Surgical Auto Suture® EndoscopicScissors, which is cleared to market underpremarket notification K903206 |
INDICATIONS FOR USE: The Applied Laparoscopic Monopolar Scissors is indicated for use in gynecologic and general endoscopic procedures for mobilization and transection of tissues. The device with a 5mm diameter insulated shaft has a male cautery connection on top of the handle and may be used for monopolar cautery when attached to standard cautery cables and their generators.
INTENDED USE: The Laparoscopic Monopolar Scissors is intended for use in general or gynecological surgical procedures that utilize minimally invasive surgical procedures. The primary function of the device is to provide the surgeon the ability to manipulate tissue during minimally invasive surgery.
SUMMARY STATEMENT:
The Applied Laparoscopic Monopolar Scissors is designed to for a variety of general, gynecologic and urologic endoscopic procedures for mobilization and transection of
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Page 2 of 3
tissue. The Applied Laparoscopic Monopolar Scissors consists of a reusable handle and disposable insulated shaft with scissor blades. The device has a 5mm diameter disposable insulated shaft that connects to a reusable Polyenylsulfone/stainless steel handle with a male cautery connector to be utilized for monolpolar cautery when attached to standard monopolar cautery cables and their generators.
The disposable shaft consists of a stainless steel outer shaft housing an actuation rod, which connects to the scissor blades and handle actuation rod. The disposable shaft is to be supplied sterile in single unit pouches. The scissor blade length is 17.4mm and the blade opening is 5.59mm and will be available in working lengths of 32cm, 38cm, and 45cm.
The reusable handle is comprised of Polyphenylsulfone male and female handles with various stainless connectors and contacts. The reusable handle will be supplied non-sterile. The handle includes a 360° rotation knob for user convenience.
The reusable handle is steam sterilized by the user and then connected to the sterile disposable shaft. Following use the shaft and handle are disassembled. The shaft is disposed of and the handle is cleaned and re-sterilized.
The device is in compliance with ISO 10993 for Biocompatibility. The Applied Laparoscopic Monopolar Scissors Shaft is sterilized using 100% Ethylene Oxide (EO). Applied's 100% EO sterilization cycle provides a sterility assurance level of 106. Sterilization validation for Applied Medical's EO cycle uses three halfcycle validation runs, which incorporate biological indicators and temperature monitors distributed throughout the load to verify gas penetration and profile temperature distribution. Spore strip biological indicators (BIs) of Bacillius atrophaus var. niger (formerly known as Bacillus subtilis) with a population of 106 are used to monitor routine finished product sterilization loads. Sterilant residue levels will be in compliance with ANSVAAMI/ISO 10993-7:1995 for limited exposure devices which is 20 mg ethylene oxide and 12 mg ethylene chlorohydrin.
The Laparoscopic Monopolar Scissors Handle is provided non-sterile. Sterilization instructions are provided in the Product Information Data Sheet. The Applied steam sterilization and cleaning validation methods are based on the AAMI TIR No. 12 - 1994, Designing, Testing and Labeling Reusable Devices for Reprocessing in Health Care Facilities: A Guide for Device manufactures, and proves a sterility assurance level of 106. Sterilization validation of the steam sterilizations is based on three sterilization cycles at one-half the exposure time. The use of Bacillus sterothermophilus spore strips or inoculum is the utilized indicator.
The Laparoscopic Monopolar Scissors is substantially equivalent to the United States Surgical Auto Suture® Endoscopic Scissors, which is cleared to market
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KO40295
Page 3 of 3
under premarket notification K903206, in intended use, design, and use methodology and is manufactured from similar materials.
Applied Medical is the manufacturer of the device and has followed design control regulations per 21 CFR § 820.30. The design controls have been in place since 1997 and have been audited by FDA on several occasions. The design of the Laparoscopic Monopolar Scissors was within the Applied Medical Design Control System.
A Design Risk Assessment Profile was conducted in accordance to Applied Medical internal Stand Operating Procedures, EN 1441 standards, ISO 9001/ISO 13485, AAMI/ISO TIR 14971, and 21 CFR § 820.30, validation and verification activities addressed the profile. Based on the risk analysis, validation and verification activities were formally controlled and addressed by Applied Medical, the activities included the methods, tests used, and acceptance criteria applied.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird-like figure with three wing-like extensions.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 2 2004
Applied Medical Resources Co. % Ms. Elizabeth Drew Underwriters Laboratories, Inc. Santa Clara Division 1655 Scott Boulevard SANTA CLARA CA 95050-4169 Re: K040295 Trade/Device Name: AMRC's Laparoscopic Monopolar Scissors Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: 85 HET Dated: February 23, 2004 Received: February 26, 2004
Dear Ms. Drew:
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 (PMA), 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.
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 fisting (2) 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,
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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 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 the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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INDICATIONS FOR USE
Applied Medical Resources is providing this separate cover page for the Applied Applied Medical Resources is prs "Indications for Use" as required.
K04 0295 Not assigned 510(k) Number:
Applied Laparoscopic Monopolar Scissors Device Name:
The Applied Laparoscopic Monopolar Scissors is indicated for use Indications for Use: in gynecologic and general endoscopic procedures for mobilization and transection of in gynecologic and general chaoscopic processed shaft has a male cautery connection on tissues. The device with a min diamotor instituted cautery when attached to standard cautery cables and their generators.
Title: Director RA/Clinical Programs_ Date: 1/15/04 Signature:
(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)
Over-The -Counter Use OR
Nancy Brogdon
(Division Sign-OHX)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K040295
11 of 26
§ 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.