(150 days)
The LAPARETTE is intended for use in minimally invasive surgery, including laparoscopy, to cut tissue and control bleeding by use of highfrequency electrical current, irrigate tissue and cavities, as well as suction fluids from the wound. This device is not intended for use in tubal sterilization procedures.
The LAPARETTE is a hybrid device consisting of three reusable (Handle, Electrode-Cannula, and Insulated Sleeve) and two single use components (Cartridge and Sheath). All LAPARETTE components are supplied non-sterile, requiring sterilization by the health care facility before use. The LAPARETTE is sold both as a set and as individual products.
The provided text is a 510(k) summary for the LAPARETTE device and does not contain detailed information about acceptance criteria or a specific study proving the device meets them. The summary focuses on establishing substantial equivalence to predicate devices based on intended use, design, and general operating characteristics, rather than presenting a performance study against predefined acceptance criteria.
The document mentions "Bench and animal testing provided in the 510(k) was used to characterize the performance of the LAPARETTE," but it does not elaborate on the specific tests, their results, or the acceptance criteria for those tests.
Therefore, I cannot populate the requested tables or answer all questions as the necessary information is not present in the provided text.
Here is what can be inferred or stated based on the available text:
Acceptance Criteria and Device Performance Study
The provided 510(k) summary (K971146) for the LAPARETTE device does not explicitly state specific acceptance criteria in a quantitative manner, nor does it detail a comprehensive study that proves the device meets such criteria in the way a clinical trial report would.
The basis for substantial equivalence is primarily founded on comparison to predicate devices regarding:
- Intended use
- Design considerations
- General operating characteristics
The document states, "Bench and animal testing provided in the 510(k) was used to characterize the performance of the LAPARETTE." However, it does not provide details on the methodology, results, or specific acceptance thresholds for these tests.
Given the information, a table of acceptance criteria and reported device performance cannot be generated as requested. Similarly, detailed answers to questions concerning sample size, expert involvement, adjudication methods, or specific study types (MRMC, standalone) are not available.
Below is a partial response based on the limited inferences possible from the text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Predicate Device Comparison) | Reported Device Performance (Inferred from Predicate Device Comparison) |
|---|---|
| Intended Use: - Electrocautery (cutting and bleeding control) - Irrigation - Suction | LAPARETTE performs electrocautery, irrigation, and suction. |
| Operating Characteristics: - Monopolar use | LAPARETTE is designated for monopolar use only. |
| Dimensions: - Usable shaft length: ~30-35mm - Shaft O.D.: ~5.0-5.4mm | LAPARETTE usable shaft length: 30.5 mm LAPARETTE shaft O.D. within range. |
| Material Compatibility: - Use of polymers common to medical devices | LAPARETTE uses polymers common to various medical devices. |
| Tip Rotation Feature (for comparison with D&G Multi-Function) | LAPARETTE features tip rotation. |
| Tip Shielding during insertion (for comparison with Ethicon Probe Plus) | LAPARETTE features the ability to shield the tip during insertion. |
| Sterilization: (implicit requirement for reusable components) | Reusable components require steam sterilization; protective sheath requires ethylene oxide. |
2. Sample size and Data Provenance
The document mentions "Bench and animal testing" but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts and Qualifications
Not specified in the provided text. Ground truth for the performance tests is not explicitly defined with expert involvement.
4. Adjudication method
Not specified for any testing done.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study
No MRMC study is mentioned. The primary method for establishing equivalence is comparison to predicate devices, not improvement over human readers.
6. Standalone performance (algorithm only without human-in-the-loop performance)
While "Bench and animal testing" were performed, the details are not provided. It is likely these were standalone performance tests of the device's physical and functional capabilities, but this is not definitively stated or elaborated upon for an "algorithm only" context, as this is a surgical instrument and not an AI/software device.
7. Type of ground truth used
For the "Bench and animal testing," the specific type of ground truth is not elaborated. Given the nature of a surgical electrosurgical instrument, "ground truth" would likely relate to objective measurements of cutting efficacy, coagulative properties, irrigation flow rates, suction effectiveness, mechanical integrity, and biocompatibility, as determined by standard engineering and biological testing rather than expert consensus on diagnostic images or pathology.
8. The sample size for the training set
Not applicable. This device is a physical surgical instrument, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable (as above).
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510(k) Summary RD CHUS, Inc. LAPARETTE (per 21 CFR 807.92)
PI 02
AUG 25 1997
| 1. DATE OF PREPARATION: | March 27, 1997 |
|---|---|
| 2. SPONSOR/APPLICANT: | RD CHUS Inc.3001, 12th ave North,Fleurimont, Quebec, Canada, J1H 5N4 |
| 3. CONTACT NAME: | Fernand JalbertTelephone: 819-563-5555 Ext. 14252 |
| 4. DEVICE NAME: | |
| Trade/Proprietary Name:Common/Usual Name: | LAPARETTEElectrosurgical electrode, suction, irrigation |
IDENTIFICATION OF THE PREDICATE OR LEGALLY MARKETED DEVICE(S) TO 5. WHICH EQUIVALENCE IS BEING CLAIMED:
device or laparoscopic accessory
Accessory to electrosurgical cutting and coagulation
Davis + Geck's Multi-Function Pistol Grip (K921696) American Cyanamid Co.
Ethicon Endopath Probe Plus (K912492) Ethicon, Inc.
6. DEVICE DESCRIPTION:
Classification Name:
INTENDED USE: The LAPARETTE is intended for use in minimally invasive surgery, including laparoscopy, to cut tissue and control bleeding by use of highfrequency electrical current, irrigate tissue and cavities, as well as suction fluids This device is not intended for use in tubal sterilization from the wound. procedures.
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K971146 p 2022
OVERVIEW: The LAPARETTE is a hybrid device consisting of three reusable (Handle, Electrode-Cannula, and Insulated Sleeve) and two single use components (Cartridge and Sheath). All LAPARETTE components are supplied non-sterile, requiring sterilization by the health care facility before use. The LAPARETTE is sold both as a set and as individual products. Bench and animal testing provided in the 510(k) was used to characterize the performance of the LAPARETTE.
- BASIS FOR SUBSTANTIAL EQUIVALENCE: RD CHUS Inc. makes the claim of 7. substantial equivalence to the above devices based on intended use, design considerations, and general operating characteristics. All three devices share the same intended use of electrocautery, irrigation, and suction using the same instrument. All three products are designated for monopolar use only. While the D&G Multi-Function and Ethicon Probe Plus are single use only, the LAPARETTE is a hybrid of reusable and single use devices. The recommended sterilization technique for the LAPARETTE is steam for all but the Protective Sheath which requires ethylene oxide sterilization. Although the specific materials of construction are different, all cited devices use polymers common to various medical devices. All three products use a pistol grip handle design. The LAPARETTE uses a separate disposable cartridge, while that function is integral to the handles of the D&G Multi-Function and Ethicon Probe Plus. The LAPARETTE and the D&G Multi-Function share the feature of tip rotation, while the Ethicon Probe Plus requires that the entire device is rotated. While the LAPARETTE and the Ethicon Probe Plus feature the ability to shield the tip during insertion into the wound by providing the ability to retract the sheath over the exposed tip, the D&G Multi-Function does not allow retraction. The dimensions of all three devices are similar with usable shaft lengths of 30.5 mm for the LAPARETTE, 31.75 mm for the D&G Multi-Function, and 35 mm for the Ethicon Probe Plus. Shaft O.D.s range from 5.0 mm to 5.4 mm. Devices are compatible with trocar sizes of 5.5 (LAPARETTE) and 5.0 for the other devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The words "DEPARTMENT OF HEALTH & HUM" are arranged in a circular fashion around the bird.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 25 1997
RD CHUS, Inc. c/o Rosina Robinson, R.N., RAC Medical Device Consultants, Inc. Staff Consultant 49 Plain Street North Attleboro, Massachusetts 02760
Dear Ms. Robinson:
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 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.
Re: K971146 Laparette
Dated: July 9, 1997. . . .
Received: July 10, 1997 Regulatory class: II
21 CFR §884.4160/Product code: 85 KNF
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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result 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 does not affect any obligation you might have under sections 531 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 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 question 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/dsmamain.html".
Sincerely yours,
h. William Yin
Lillian Yin, Ph.D. 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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1297146 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use: The LAPARETTE is an electrosurgical instrument with integral suction and irrigation capability. It is intended for use in minimally invasive surgery, including laparoscopy, to cut tissue and control bleeding by use of high-frequency elsetrical current, to irrigate tissue and cavities, as well as to suction fluids from the wound. This device is not intended for use in tubal sterilization procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Sathing /
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number: K971146
Prescription Use ✓
(Per 21 CFR 801.109)
OR Over-The-Counter Use __
(Optional Format 1-2-96)
§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).