(150 days)
Not Found
No
The summary describes a surgical instrument for cutting, controlling bleeding, irrigating, and suctioning. There is no mention of AI, ML, image processing, or any data-driven decision-making capabilities. The performance studies are based on bench and animal testing, not training or testing of an AI/ML model.
Yes
No
Explanation: The device description states its purpose is to "cut tissue and control bleeding by use of high-frequency electrical current, irrigate tissue and cavities, as well as suction fluids from the wound" during minimally invasive surgery. These functions are therapeutic and surgical, not diagnostic.
No
The device description explicitly states it is a "hybrid device consisting of three reusable and two single use components," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during surgery to cut tissue, control bleeding, irrigate, and suction. This is a therapeutic and surgical function, not a diagnostic one performed on samples outside the body.
- Device Description: The description of the components (handle, electrode-cannula, insulated sleeve, cartridge, sheath) and their function (using high-frequency electrical current) aligns with surgical tools, not devices used for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The LAPARETTE's function is directly related to performing a surgical procedure on the patient's body.
N/A
Intended Use / Indications for 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 from the wound. This device is not intended for use in tubal sterilization procedures.
Product codes (comma separated list FDA assigned to the subject device)
85 KNF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench and animal testing provided in the 510(k) was used to characterize the performance of the LAPARETTE.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 Jalbert |
| Telephone: 819-563-5555 Ext. 14252 | |
| 4. DEVICE NAME: | |
| Trade/Proprietary Name: | |
| Common/Usual Name: | LAPARETTE |
| Electrosurgical 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.
1
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.
2
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
3
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)