(77 days)
The Tissue Retractor System is intended for use in dissecting and retracting in all types of surgical procedures requiring dissection and retraction of tissue.
The RadLite™ Tissue Retractor System has application for the creation and maintenance of an operative cavity in the extraperitoneal spaces such as the retroperitoneal, preperitoneal and subcutaneous areas. The device may be used in all types of surgical procedures requiring retraction of tissue.
The Genzyme Tissue Retractor System s is a surgical instrument that provides a means to create and maintain a cavity by retracting the subcutaneous layer to expose the conduit. The retraction is sufficient to allow enough exposure to dissect and retract subcutaneous tissue for performing all types of surgical procedures. This system consists of the following components:
- Handle: The handle securely holds the retractor blade, light panel, and provides a host adaptor for ACMI connection to a variety of commercially available light sources.
- Retractor/blade: The stainless steel retractor blade attaches to the handle for lifting the subcutaneous layer.
- Fiber Optic Light Panel: The light panel fits securely into the handle on the underside of the retractor blade to provide illumination for the procedure.
The provided document, K022989, is a 510(k) Summary of Safety and Effectiveness for the "Tissue Retractor System" from Genzyme Biosurgery. It focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information regarding acceptance criteria or a study proving device performance against such criteria.
The document primarily covers:
- Manufacturer Information: Genzyme Biosurgery
- Device Identification: Tradename (Tissue Retractor System), Classification (Endoscopic Instruments and Accessories per 21 CFR §876.1500), Common Name (Tissue Retractor).
- Predicate Devices: SaphLITE® System (K960400) by Genzyme Biosurgery and ENDOPATH® Ultra-Retractor (K973139) by Ethicon Endo-Surgery, Inc.
- Device Description: Components (Handle, Retractor/blade, Fiber Optic Light Panel) and function (creating and maintaining a cavity by retracting the subcutaneous layer).
- Intended Use: Dissecting and retracting in all types of surgical procedures requiring dissection and retraction of tissue.
- Comparison of Characteristics: States "The technological characteristics of the New Device are the same as the predicate devices."
- Conclusion of Substantial Equivalence: Based on detailed device description, conformance to consensus standards, and voluntary standards.
- FDA Response Letter: Confirms substantial equivalence and outlines regulatory responsibilities.
- Indications for Use: Reiterates the intended use in extraperitoneal spaces and for tissue retraction in all types of surgical procedures.
Therefore, I cannot populate the table or answer the questions regarding acceptance criteria and performance studies because this information is not present in the provided text. The 510(k) pathway often relies on demonstrating equivalence to existing legally marketed devices rather than conducting extensive performance studies against specific acceptance criteria for a novel technology that would require such detailed reporting.
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KO22989 1/2
510(k) Summary of Safety and Effectiveness
1. MANUFACTURER:
Genzyme Biosurgery A division of GENZYME CORORATION 600 Airport Road Fall River, MA 02720
NOV 2 5 2002
Contract: Karen K. Sylvia, Sr. Regulatory Specialist Date Prepared: 6 September, 2002
2. DEVICE:
| Tradename: | Tissue Retractor System |
|---|---|
| Classification: | Endoscopic Instruments and Accessories per 21 CFR §876.1500) |
| Common Name: | Tissue Retractor |
3. PREDICATE DEVICE:
The predicate devices used to determine substantial equivalence for the Genzyme Tissue Retractor System, are the SaphLITE® System marketed by Genzyme Biosurgery, Fall River, MA 02720 (K960400), and the ENDOPATH® Ultra-Retractor marketed by Ethicon Endo-Surgery, Inc. (K973139)
4. DEVICE DESCRIPTION:
The Genzyme Tissue Retractor System s is a surgical instrument that provides a means to create and maintain a cavity by retracting the subcutaneous layer to expose the conduit. The retraction is sufficient to allow enough exposure to dissect and retract subcutaneous tissue for performing all types of surgical procedures. This system consists of the following components:
- Handle: The handle securely holds the retractor blade, light panel, and provides a ロ host adaptor for ACMI connection to a variety of commercially available light sources.
- Retractor/blade: The stainless steel retractor blade attaches to the handle for lifting the subcutaneous layer.
- Fiber Optic Light Panel: The light panel fits securely into the handle on the underside of the retractor blade to provide illumination for the procedure.
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5. INTENDED USE:
The Tissue Retractor System is intended for use in dissecting and retracting in all types of surgical procedures requiring dissection and retraction of tissue.
6. COMPARISON OF CHARACTERISTICS:
The technological characteristics of the New Device are the same as the predicate devices.
The determination of substantial equivalence for this device was based on a detailed device description, conformance to consensus standards and voluntary standards.
Based on the 510(k) summaries and 510(k) statements (21 CFR §807 and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Devices under the Federal Food, Drug and Cosmetic Act.
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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three lines forming its body and wings. The words "HUMAN SERVICES • USA" are arranged in a circular pattern around the top of the logo. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 5 2002
Genzyme Biosurgery Karen K. Sylvia Senior Regulatory Specialist 600 Airport Road Fall River, Massachusetts 02720
Re: K022989
Trade/Device Name: Tissue Retractor System Regulation Number: 878.4580 Regulation Name: Surgical endoscopic light Regulatory Class: Class II Product Code: FSW Dated: September 6, 2002 Received: September 9, 2002
Dear Ms. Sylvia:
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
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Page 2 – Ms. Karen K. Sylvia
quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 (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 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C Paatz
(c' Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number K022989 Device Name
RadLite™ Tissue Retractor System
Indications for Use
The RadLite™ Tissue Retractor System has application for the creation and maintenance of an operative cavity in the extraperitoneal spaces such as the retroperitoneal, preperitoneal and subcutaneous areas. The device may be used in all types of surgical procedures requiring retraction of tissue.
(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use -(Per 21 CFR & 801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)
iriam C. Provost
Division Sign-Off) " retorative Division of Ger and Neurologica ·
10(k) Nu
K022989
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.