(586 days)
Not Found
No
The description focuses on the mechanical and thermal aspects of sterilization and explicitly states the devices have substantially the same technological characteristics as previously cleared devices, with only minor mechanical modifications. There is no mention of AI or ML.
No.
The device is an autoclave intended to sterilize medical instruments, not to provide therapy to a patient.
No
Explanation: The devices are clinical autoclaves used for sterilization, not for diagnosing medical conditions.
No
The device description clearly describes a physical autoclave, which is a hardware device used for sterilization. There is no mention of software being the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "sterilize unwrapped solid instruments and non-porous loads." This is a sterilization process for medical devices, not a diagnostic test performed on biological samples.
- Device Description: The description details the physical characteristics and function of an autoclave, which is a sterilization device. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is clearly intended for the sterilization of medical instruments, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Models 2100 06 and 2100 07 Clinical Autoclaves are intended to sterilize unwrapped solid instruments (i.e., excluding lumened instruments and dental handpieces) and non-porous loads at cycle parameters of 121° Celsius saturated steam process for 18 minutes
Product codes (comma separated list FDA assigned to the subject device)
FLE
Device Description
The Series 2100 clinical autoclaves by Prestige Medical are Model numbers 2100 07 (extended body) and 2100 06 (standard body). Both are 120 volt autoclaves, which have a 18 minute sterilization cycle at 121°C. The height of the extended body autoclave is slightly greater than that of the standard body (420mm versus 335mm).
The devices have substantially the same technological characteristics as the devices cleared under K910789 and K900432, and the identical materials, design, composition and function as the products currently marketed under K910789 and K900432. The slight modification reflected in the subject devices is that the "plug and pintle," which performed air bleed, pressure indicator and excess pressure relief functions, has been replaced by three separate components, each of which fulfills one of the functions formerly performed by the plug and pintle. The three separate components are: an air bleed device; a pressure rise indicator in the lid of the product; and a gasket blow-out slot through which a sealing gasket may extrude if necessary.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 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
- (1) Submitter:
MAR - 3 1998
Prestige Medical P.O. Box 154 Off Clarendon Road Blackburn, Lancashire BB1 9UG United Kingdom
Contact Person: Robert N. Stevenson
Date Summary Prepared: February 20, 1998
Device Proprietary Name: Prestige Medical Series 2100 Clinical Autoclave (2)
Common Name: autoclave
Classification Name: steam sterilizer
- KaVoKlave Steam Autoclave, K910789 (3) Predicates: #M8 Electronic Sterilizer, K900432
- Device Description: The Series 2100 clinical autoclaves by Prestige Medical are (4) Model numbers 2100 07 (extended body) and 2100 06 (standard body). Both are 120 volt autoclaves, which have a 18 minute sterilization cycle at 121°C. The height of the extended body autoclave is slightly greater than that of the standard body (420mm versus 335mm).
- Intended Use: The autoclaves are intended to sterilize unwrapped solid (5) instruments (i.e., excluding lumened instruments and dental handpieces) and non-porous loads at cycle parameters of 121℃ saturated steam process for 18 minutes.
- (6) The devices have substantially the same technological characteristics as the devices cleared under K910789 and K900432, and the identical materials, design, composition and function as the products currently marketed under K910789 and K900432. The slight modification reflected in the subject devices is that the "plug and pintle," which performed air bleed, pressure indicator and excess pressure relief functions, has been replaced by three separate components, each of which fulfills one of the functions formerly performed by the plug and pintle. The three separate components are: an air bleed device; a pressure rise indicator in the lid of the product; and a gasket blow-out slot through which a sealing gasket may extrude if necessary.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine and health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 3 1998
Mr. Mark A. Heller ·Prestige Medical C/O Hale and Dorr LLP 1455 Pennsylvania Avenue, N.W. Washington, DC 20004
Re: K962903 Trade Name: Prestige Medical Series 2100 Clinical Autoclave Regulatory Class: II Product Code: FLE Dated: December 23, 1997 Received: December 23, 1997
Dear Mr. Heller:
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, labeling, and prohibitions against 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. Anno an substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug 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
2
Page 2 - Mr. Heller
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 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 labelinq regulation (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,
Timothy A. Ulatowski
Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page _ 1 _ of _ 1
510(k) Number (if known): K962903
Prestige Medical Series 2100 Clinical Autoclaves Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Models 2100 06 and 2100 07 Clinical Autoclaves are intended to sterilize unwrapped solid instruments (i.e., excluding lumened instruments and dental handpieces) and non-porous loads at cycle parameters of 121° Celsius saturated steam process for 18 minutes
(FLEASE DO NOT WRITE RELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number.
(Optional Format 1-2-96)
Over-the-Counter Use