(165 days)
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No
The document describes a steam sterilizer and contains no mention of AI, ML, or related concepts.
No
Explanation: This device is a sterilizer for medical and dental instruments, not a device used for treating diseases or health conditions.
No
The device is described as a "sterilizer," which processes medical instruments, not a device used for diagnosis of a condition or disease in a patient.
No
The device is a steam sterilizer, which is a hardware device used for sterilization, not a software-only medical device.
Based on the provided information, the W&H Lisa Water Steam Sterilizer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the sterilization of medical and dental instruments. This is a process performed on devices used in medical procedures, not a test performed on a biological sample to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
The device is clearly intended for the sterilization of medical equipment, which falls under the category of medical devices used for infection control and reprocessing.
N/A
Intended Use / 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 |
Product codes
FLE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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§ 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).
0
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.
1
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