(143 days)
Laparoscopic Retractors are designed to retract or elevate organs and tissues to provide better visualization access to surgical sites during minimally invasive laparoscopic procedures.
The proposed Laparoscopic retractors are inserted through the trocar cannula and into the abdomen in order to provide visualization during laparoscopic surgery by retracting and manipulating organs at the surgical site.
The provided text describes a 510(k) premarket notification for Laparoscopic Retractors by Cardinal Health. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study with detailed metrics typically associated with AI/software devices.
Therefore, many of the requested categories are not applicable to the information provided. The document primarily details the regulatory process and asserts equivalence based on design, materials, and functional characteristics.
Here's an analysis based on the provided text, indicating where information is not available or not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Materials used in device must be acceptable for intended use as per ISO 10993 Part-1 "Biological Evaluation of Medical Devices". | "All materials used in the fabrication of the Laparoscopic Retractors were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 'Biological Evaluation of Medical Devices'. These materials also were evaluated in accordance with industry recognized test methods and were found to be acceptable for the intended use." |
| Functional Equivalence: Device performance must demonstrate substantial equivalence to currently marketed predicate devices with regard to functional characteristics. | "Performance testing demonstrated that the proposed device is substantially equivalent to the currently marketed predicate devices with regard to functional characteristics." |
| Design and Material Equivalence: Device must be composed of the same or similar design, materials, and manufacturing characteristics as predicate devices. | "The proposed device and the predicate devices are composed of the same or similar design, materials and manufacturing characteristics." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The document describes non-clinical performance testing and biological qualification tests, not a clinical test set with patient data. No sample size for a "test set" of patient data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. As no clinical "test set" involving expert review is described, this information is not relevant. The "ground truth" here relates to material safety and functional equivalence, established through scientific standards (ISO 10993) and engineering performance testing. The qualifications of the personnel conducting these non-clinical tests are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method is mentioned as there is no clinical test set requiring expert consensus.
5. 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 a physical medical device (laparoscopic retractors), not an AI-assisted diagnostic or therapeutic device. No human readers or AI assistance are involved in its primary function or testing as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device. There is no algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" or basis for evaluation for this device is established through:
- Scientific Standards: Adherence to ISO 10993 Part-1 for biocompatibility.
- Engineering Performance Testing: Evaluation against industry-recognized test methods to compare functional characteristics with predicate devices.
- Material Characterization: Comparison of materials and manufacturing characteristics to predicate devices.
8. The sample size for the training set
- Not Applicable. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. No training set is mentioned.
{0}------------------------------------------------
14092684
CardinalHealth
Cardinal Health 1430 Waukegan Road McGaw Park, Illinois 60085-6787 847.578.6610 FAX: 847.785.2506
JAN 22 2010
SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Laparoscopic Retractors
| Sponsor: | Cardinal Health1430 Waukegan Road MPKBMcGaw Park, IL 60085 |
|---|---|
| Regulatory Affairs:Contact | Sharon Nichols |
| Telephone: | (847) 578-6610 |
| Date Summary Prepared: | August 2009 |
| Common Name: | Laparoscopic Retractors |
| Regulation Description: | Endoscope and Accessories |
| Device Classification name | Laparoscope, General and PlasticSurgery |
| Device Class andRegulation Number: | II21 CFR §876.1500 |
| Procode: | GCJ |
| Predicate Devices: | K933008, Laparoscopic Retractors andScraperK930667, Reusable LaparoscopicInstruments |
| Description: | The proposed Laparoscopic retractorsare inserted through the trocar cannulaand into the abdomen in order toprovide visualization during laparoscopicsurgery by retracting and manipulatingorgans at the surgical site. |
000037
، ﻭﺍﻟ
{1}------------------------------------------------
Intended Use:
Summary of Technological Characteristics:
Summary of testing:
Non-Clinical Testing:
Laparoscopic Retractors are designed to retract or elevate organs and tissues to provide better visualization access to surgical sites during minimally invasive laparoscopic procedures.
The proposed device and the predicate devices are composed of the same or similar design, materials and manufacturing characteristics.
All materials used in the fabrication of the Laparoscopic Retractors were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". These materials also were evaluated in accordance with industry recognized test methods and were found to be acceptable for the intended use.
Performance testing demonstrated that the proposed device is substantially equivalent to the currently marketed predicate devices with regard to functional characteristics.
000038
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
JAN 2 2 2010
Cardinal Health % Ms. Sharon Nichols Regulatory Affairs Manager 1430 Waukegan Road MPKB McGaw Park, Illinois 60085
Re: K092684
Trade/Device Name: Laparoscopic Retractors Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: March 21, 2010 Received: March 21, 2010
Dear Ms. Nichols:
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 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); medical device reporting (reporting of medical
{3}------------------------------------------------
Page 2 - Ms. Sharon Nichols
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N Ma Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
KO92684
CardinalHealth
1430 Waukegan Road McGaw Park, Illinois 60085-6787 847.578.6442 FAX: 847.785.2506
Indication for Use
510(k) Number (if known):
Device Name:
Laparoscopic Retractors
Indications For Use:
Laparoscopic Retractors are designed to retract or elevate organs and tissues to provide better visualization access to surgical sites during minimally invasive laparoscopic procedures.
Prescription Use _X
Over-The Counter Use
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
or
Concurrence of CDRH, Office of Device Exaluation (ODE) SMU
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_K092684
000032
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.