(70 days)
Reprocessed unipolar laparoscopic/endoscopic instruments, including scissors, dissectors, and graspers are intended for use in minimally invasive surgical procedures. Reprocessed unipolar laparoscopic/endoscopic instruments, including scissors, dissectors, and graspers, are to be used for patients requiring minimally invasive surgical procedures to manipulate and manage internal soft tissue by grasping, cutting, dissecting, cauterizing, or coagulating tissue.
Unipolar laparoscopic/endoscopic instruments are electrosurgical instruments consisting of a rigid plastic handpiece with loop handles connected to the distal end effector jaw by an elongated, narrow-diameter insulated barrel or shaft. The devices are designed to be inserted through an appropriately sized trocar sleeve or cannula. The jaws are operated by the handpiece loop handles and may be shaped as scissors, dissectors or graspers. The jaws of some models may be rotated by manipulating controls on the handpiece. The blades or jaws of unipolar laparoscopic/endoscopic instruments can deliver a cauterizing current that enters the instrument through the unipolar cautery connector on the handpiece, runs down the insulated shaft and through the tissue in the blades or jaws.
The provided documentation describes the reprocessing of laparoscopic/endoscopic instruments, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (e.g., sample sizes for training/test sets, ground truth establishment for training, number of experts, adjudication methods, MRMC studies, standalone performance, effect size of AI assistance) are not applicable.
The document does, however, provide information regarding performance testing to ensure the reprocessed devices meet their acceptance criteria and perform as originally intended.
Acceptance Criteria and Device Performance (Reprocessed Unipolar Laparoscopic/Endoscopic Instruments)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Continuity | All reprocessed unipolar laparoscopic/endoscopic instruments are tested for electrical continuity. (Implicitly, they must pass this test to be deemed reprocessed successfully). |
| Cutting Function (for Scissors) | Reprocessed unipolar laparoscopic/endoscopic scissors are tested for cutting function. (Implicitly, they must demonstrate effective cutting). |
| Grasping Function (for Graspers and Dissectors) | Graspers and dissectors are tested for the ability of the jaws to grasp appropriately. (Implicitly, they must demonstrate appropriate grasping). |
| Removal of Adherent Visible Soil | Alliance Medical Corporation's reprocessing process includes removal of adherent visible soil. (This is a procedural step that leads to meeting a cleanliness criterion). |
| Decontamination | Alliance Medical Corporation's reprocessing process includes decontamination. (This is a procedural step that leads to meeting a sterility/disinfection criterion, though specific metrics are not provided). |
| Performance as Originally Intended | "Performance data demonstrates that Reprocessed Unipolar Laparoscopic/Endoscopic Instruments perform as originally intended." This is an overarching conclusion based on the testing performed. The intended use includes manipulating and managing internal soft tissue by grasping, cutting, dissecting, cauterizing, or coagulating tissue. |
| Substantial Equivalence to Predicate Devices | The conclusion states that the reprocessed device is "safe, effective and substantially equivalent to the predicate devices" based on the information provided. This implies that the performance characteristics are comparable to those of the new, legally marketed predicate devices. |
Since this document describes reprocessed medical devices and not an AI/ML device, the following points are not applicable and thus cannot be filled in from the provided text:
- Sample size used for the test set and the data provenance: Not applicable for a reprocessed medical device's functional testing. The testing likely involves a sample of reprocessed devices, but specific numbers and provenance are not detailed as they would be for a dataset in an AI study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would be objective functional performance (e.g., does it cut, does it grasp, is it electrically continuous).
- Adjudication method for the test set: Not applicable. Functional tests typically have objective pass/fail criteria.
- 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: Not applicable. This is for AI/ML devices.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI/ML devices.
- The type of ground truth used: For reprocessed devices, the "ground truth" is the established functional specification of the original device and the objective criteria for cleanliness, electrical integrity, and mechanical function.
- The sample size for the training set: Not applicable. There is no AI model being trained.
- How the ground truth for the training set was established: Not applicable. There is no AI model being trained.
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OCT 22 2001
PART B: 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter:
KO 12625 Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044
Contact:
Don Selvey Vice President, Regulatory Affairs and Quality Assurance (480) 763-5300
Date of preparation:
August 10, 2001
Name of device:
Trade/Proprietary Name: Reprocessed Unipolar Laparoscopic/Endoscopic Instruments
Common or Usual Name: Unipolar Laparoscopic/Endoscopic Instruments
Classification Name: Endoscope and Accessories and/or Electrosurgical Cutting and Coagulation Device and Accessories
Reprocessed devices:
| Manufacturer | Description | Model |
|---|---|---|
| Ethicon | Endopath ® Endo Metzenbaum Scissor | BMS10 |
| Ethicon | Endopath ® Curved Scissor | DCS12 |
| Ethicon | Endopath ® Hook Scissor | DHS14 |
| Ethicon | Endopath ® Micro-Scissor | DMS15 |
| Ethicon | Endopath ® Curved Scissor | 5DCS |
| Ethicon | Endopath ® Curved Scissor, Short | SCS12 |
| Ethicon | Endopath ® Straight Grasper | DSG22 |
| Ethicon | Endopath ® Modified Allis Grasper | DSG23 |
| Ethicon | Endopath ® Ratchet Grasper | 5DSG |
| Ethicon | Endopath ® Claw Extractor | DEX41 |
| Ethicon | Endopath ® Curved Dissector | DCD32 |
| Ethicon | Endopath ® Straight Dissector | DSD33 |
| Ethicon | Endopath ® Curved Dissector | 5DCD |
| Ethicon | Endopath ® Curved Dissector | SCD32 |
Predicate device(s):
| K# | Device Description | Procode |
|---|---|---|
| K984240 | Ethicon Endopath ® Endoscopic Instrument | GEI |
| Ethicon Endopath ® Endoscopic | ||
| K934784 | Electrosurgical Forceps | GEI |
| Ethicon Endopath ® Endoscopic Surgical | ||
| K930933 | Instruments | GCJ |
Alliance Medical Corporation Reprocessed Laparoscopic/Endoscopic Instruments Traditional 510(k)
9
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| Devicedescription: | Unipolar laparoscopic/endoscopic instruments are electrosurgicalinstruments consisting of a rigid plastic handpiece with loop handlesconnected to the distal end effector jaw by an elongated, narrow-diameter insulated barrel or shaft. The devices are designed to beinserted through an appropriately sized trocar sleeve or cannula. Thejaws are operated by the handpiece loop handles and may be shapedas scissors, dissectors or graspers. The jaws of some models may berotated by manipulating controls on the handpiece. |
|---|---|
| The blades or jaws of unipolar laparoscopic/endoscopic instruments candeliver a cauterizing current that enters the instrument through theunipolar cautery connector on the handpiece, runs down the insulatedshaft and through the tissue in the blades or jaws. | |
| Intended use: | Reprocessed unipolar laparoscopic/endoscopic instruments, includingscissors, dissectors, and graspers are intended for use in minimallyinvasive surgical procedures. |
| Indicationsstatement: | Reprocessed unipolar laparoscopic/endoscopic instruments, includingscissors, dissectors, and graspers, are to be used for patients requiringminimally invasive surgical procedures to manipulate and manageinternal soft tissue by grasping, cutting, dissecting, cauterizing, orcoagulating tissue. |
| Technologicalcharacteristics: | The intended use and technological features of the reprocessed devices donot differ from the legally marketed predicate device(s). Both thereprocessed device(s) and the predicate device(s) have the same materialsand product design. The technological characteristics of the reprocessedunipolar laparoscopic/endoscopic scissors, dissectors, and graspers are thesame as those of the legally marketed predicate devices. |
| Alliance Medical Corporation's reprocessing of unipolarlaparoscopic/endoscopic instruments includes removal of adherent visiblesoil and decontamination. All unipolar laparoscopic/endoscopic instrumentsare tested for electrical continuity. Unipolar laparoscopic/endoscopicscissors are tested for cutting function. Graspers and dissectors are testedfor the ability of the jaws to grasp appropriately. | |
| Performancedata: | Performance data demonstrates that Reprocessed UnipolarLaparoscopic/Endoscopic Instruments perform as originally intended. |
| Conclusion: | In accordance with the Federal Food, Drug and Cosmetic Act, 21CFR Part 807 and based on the information provided in thispremarket notification, Alliance Medical Corporation concludes thatthe modified device (Reprocessed Unipolar Laparoscopic/EndoscopicInstruments) is safe, effective and substantially equivalent to thepredicate devices as described herein. |
.
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Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a triple helix design representing the interconnectedness of health, science, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus, indicating the department's name and national affiliation.
OCT 22 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Don Selvey Vice President, Regulatory Affairs and Ouality Assurance Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044
Re: K012625
Trade/Device Name: Reprocessed Unipolar Laparoscopic/Endoscopic Instruments Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 10, 2001 Received: August 13, 2001
Dear Mr. Selvey:
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 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.
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Page 2 - Mr. Don Selvey
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter will and my Journe FDA finding of substantial equivalence of your device to a legally premated notification " 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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). Other general information on your responsibilities under the Act may be obtained from the Oixision 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,
Susan Walker, us
Image /page/3/Picture/5 description: The image contains a handwritten symbol or character. It appears to be a cursive letter, possibly an 'h' or a stylized 'l', with a small flourish or stroke extending to the right. The character is drawn with thick lines, suggesting it was written with a marker or pen with a broad tip.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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II. Indications for Use Statement
K012625 510(k) Number (if known):
Device Name: Alliance Medical Corporation Reprocessed Unipolar Laparoscopic/Endoscopic Instruments
Indications for Use: Reprocessed Unipolar Laparoscopic/Endoscopic Instruments, including scissors, dissectors, and graspers, are to be used for patients requiring minimally invasive surgical procedures to manipulate and manage internal soft tissue by grasping, cutting, dissecting, cauterizing, or coagulating tissue.
| Manufacturer | Description | Model |
|---|---|---|
| Ethicon | Endopath® Endo Metzenbaum Scissor | BMS10 |
| Ethicon | Endopath® Curved Scissor | DCS12 |
| Ethicon | Endopath® Hook Scissor | DHS14 |
| Ethicon | Endopath® Micro-Scissor | DMS15 |
| Ethicon | Endopath® Curved Scissor | 5DCS |
| Ethicon | Endopath® Curved Scissor, Short | SCS12 |
| Ethicon | Endopath® Straight Grasper | DSG22 |
| Ethicon | Endopath® Modified Allis Grasper | DSG23 |
| Ethicon | Endopath® Ratchet Grasper | 5DSG |
| Ethicon | Endopath® Claw Extractor | DEX41 |
| Ethicon | Endopath® Curved Dissector | DCD32 |
| Ethicon | Endopath® Straight Dissector | DSD33 |
| Ethicon | Endopath® Curved Dissector | 5DCD |
| Ethicon | Endopath® Curved Dissector | SCD32 |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
(Division Sign-Off)
General, Restorative
510(k) Number K012625
CONFIDENTIAL
Alliance Medical Corporation Reprocessed Laparoscopic/Endoscopic Instruments Traditional 510(k)
or
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.