(52 days)
The suction devices, when attached to an external source of vacuum, are used for aspiration, removal, or sampling of body fluids during surgical procedures.
These devices are rigid, hollow tips or tubes, that when attached to an external source of vacuum are used for aspiration, removal, or sampling of body fluids during surgical procedures. Some suction devices are fitted with Fiber Optic bundles.
The provided text is a 510(k) premarket notification letter from the FDA to Walter Lorenz Surgical, Incorporated, regarding "Suction Instrumentation." It is a regulatory document stating that the device is substantially equivalent to legally marketed predicate devices.
This document does not contain any information regarding specific acceptance criteria, performance metrics, or details of a study (clinical or otherwise) that would prove the device meets such criteria.
Therefore, I cannot fulfill your request for the tables and information outlined because the source material does not provide it. The document confirms the device's regulatory classification, intended use, and substantial equivalence to existing devices but does not delve into empirical performance data or study methodologies.
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Image /page/0/Picture/2 description: The image is a black and white circular logo for the Department of Health & Human Services USA. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the top half of the circle, framing the central image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 25 1997
Ms. Diana Preston ·Requlatory Affairs Specialist Walter Lorenz Surgical, Incorporated and a 1520 Tradeport Drive Jacksonville, Florida 32218
K972074 Re : Suction Instrumentation Trade Name: Requlatory Class: II Product Code: GCX Dated: July 11, 1997 Received: July 14, 1997
Dear Ms. Preston:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labelinq, and prohibitions aqainst misbranding and adulteration.
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 requlations affecting your device can be found in the Code of Federal Requlations, 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 Requlation (OS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq 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 submission does not affect any obligation you might have under sections 531
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Page 2 - Ms. Preston
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA findinq 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (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,
Claturst
Timb Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K972074
JUL 25 1997
SUMMARY OF SAFETY AND EFFECTIVENESS }
Proprietary Name: Suction Instrumentation
Classification Name: Vacuum-Powered Body Fluid Suction Apparatus
Device Classification: Class II
Device Product Code: 80GCX (CFR 880.6740)
Intended Use: The suction devices, when attached to an external source of vacuum, are used for aspiration, removal, or sampling of body fluids during surgical procedures.
Device Description: These devices are rigid, hollow tips or tubes, that when attached to an external source of vacuum are used for aspiration, removal, or sampling of body fluids during surgical procedures. Some suction devices are fitted with Fiber Optic bundles.
Sterility Information: Devices are provided non-sterile.
The suction devices marketed by competitors displayed in Substantial Equivalence: Attachment III are believed to be substantially equivalent to Lorenz Suction Tips and Tubes based on;
- · The intended uses for devices are equivalent
- · The devices have the same technological features
- · The safety and effectiveness of the devices are equivalent
Potential Risks:
- Improper selection of tips and tubes can impair the proper function of the system ●
- . Occlusion of passageways can result in inadequate suction.
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510(k) Number (if known): unknown
)
Device Name: Lorenz Suction Tips and Tubes
The suction devices, when attached to an external source of vacuum, are -------------------------------------------------------------------------------------------------Indications For Use: used for aspiration, removal, or sampling of body fluids during surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Avilla Cucenti
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K972074
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)
§ 880.6740 Vacuum-powered body fluid suction apparatus.
(a)
Identification. A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.