(165 days)
The W&H Lisa Water Steam Sterilizer is designed for pressurized steam sterilization of medical and dental instruments (wrapped and unwrapped), including complex lumened devices (such as dental handpieces), porous and hollow loads.
Not Found
This document is an FDA 510(k) clearance letter for the W&H Lisa Steam Sterilizer. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a detailed premarket submission summary.
The provided text only lists the operational parameters for the sterilization and test cycles of the device, which are part of its intended performance but not necessarily the "acceptance criteria" as you defined them in the context of a study demonstrating device performance against specific metrics.
Therefore, I cannot provide the requested information from the given input. The document is primarily a regulatory clearance, not a performance study report.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing to the right, with flowing lines beneath them, possibly representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 7 2003
Mr. Thomas J. Louisell Regulatory Affairs Scientist A-dec. Incorporated 2601 Crestview Drive Newberg, Oregon 97132-9257
Re: K022816
Trade/Device Name: W & H Lisa Steam Sterilizer Regulation Number: 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FLE Dated: December 3, 2002 Received: December 6, 2002
Dear Mr. Louisell:
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.
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Page 2 - Mr. Louisell
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.
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) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runser
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The W&H Lisa Water Steam Sterilizer is designed for pressurized steam sterilization of medical and dental instruments (wrapped and unwrapped), including complex lumened devices (such as dental handpieces), porous and hollow loads.
It has the following automated program cycles:
Two Sterilization Cycles (summaries):
| B Standard 273 Cycle | B Standard 250 Cycle | |
|---|---|---|
| Max Temperature | 273 °F | 250 °F |
| Duration of sterilization | 4 min | 30 min |
| Pressure | 31.5 psi | 17 psi |
| Duration of drying | 15 min | 20 min |
| Total cycle time empty | 30 min | 65 min |
| Total cycle time full load | 40 min | 75 min |
| Uses: | ||
| Full solid load | Yes | Yes |
| Full porous textile load | Yes | Yes |
| Small porous items | Yes | Yes |
| Dental Handpieces | Yes | Yes |
| Unwrapped material | Yes | Yes |
| Single/double wrapped | 4.5 lbs max. wrapped | 4.5 lbs max. wrapped |
| Liquids | No | No |
Two Test Cycles (summaries):
| Bowie & Dick | Vacuum | |
|---|---|---|
| Max Temperature | 275.9 °F | None |
| Duration of sterilization | 3 min 20 sec | None |
| Max Pressure | 31.5 psi | -12.3 psi |
| Duration of drying | 4 min | None |
| Test period | N/A | 10 min |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
..............................................................................................................................................................................
Chin S. Lin
..............................................................................................................................................................................
510(k) Number: K022816
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).