(399 days)
Not Found
Not Found
No
The document describes standard autoclaves for sterilization and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
The device is an autoclave intended for sterilizing medical devices, not for therapeutic use on patients.
No
Explanation: The device is an autoclave, used for sterilizing medical devices with pressurized steam, not for diagnosis.
No
The device description explicitly states the device is an autoclave, which is a hardware device used for sterilization.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the autoclaves are for the "sterilization of heat stable medical devices; wrapped solids, hollow and porous products by means of pressurized steam." This is a process for sterilizing medical instruments and materials, not for testing samples taken from the human body (which is the core function of an IVD).
- Device Description: The device is described as an autoclave, which is a sterilization device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the Tuttnauer Horizontal Models: 4472, 5596, 6690, 6990, 66120, 69120 and 69180 autoclaves are sterilization devices, not IVDs.
N/A
Intended Use / Indications for Use
The Tuttnauer Horizontal Models: 4472, 5596, 6690, 6990, 66120, 69120 and 69180 autoclaves that are intended for use by a health care r no rathant nealized products by means of pressurized steam. The devices are intended to provide sterilization of heat stable medical devices; wrapped solids, hollow and porous products.
Product codes (comma separated list FDA assigned to the subject device)
FLE
Device Description
Not Found
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
health care
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.
Not Found
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 8, 2019
Tuttnauer Ltd. % Theodore Sullivan Official Correspondent Quarles & Brady 1701 K Street Washington, District of Columbia 20006
Re: K181456
Trade/Device Name: Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: June 6, 2019 Received: June 7, 2019
Dear Theodore Sullivan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K181456
Device Name
Tuttnauer Horizontal Models: 4472, 5596, 6690, 6990, 66120, 69120 and 69180 autoclaves
Indications for Use (Describe)
The Tuttnauer Horizontal Models: 4472, 5596, 6690, 6990, 66120, 69120 and 69180 autoclaves that are intended for use by a health care r no rathant nealized products by means of pressurized steam. The devices are intended to provide sterilization of heat stable medical devices; wrapped solids, hollow and porous products.
The standard cycles preprogrammed for the sterilizers are below.
| Model 4472 - All door configurations | ||||
|---|---|---|---|---|
| Cycle name | Sterilization | |||
| temperature | Sterilization | |||
| Time | Dry Time | Maximum Load | ||
| IUSS | 132C | 3 minutes | 1 minute | Tools - 23 kg |
| Wrapped | 132C | 4 minutes | 20 minutes | Textile -11.1 kg |
| Wrapped Tools - 23 kg | ||||
| IUSS delicate | 121C | 30 minutes | 1 minute | Tools - 23 kg |
| Wrapped delicate | 121C | 30 minutes | 20 minutes | Textile -11.1 kg |
| Wrapped Tools - 23 kg | ||||
| Bowie and Dick | 134C | 3.5 minutes | 2 minutes | N.A |
| Vacuum test | N.A | N.A | N.A | N.A |
| Model 5596 - All door configurations | ||||
|---|---|---|---|---|
| Cycle name | Sterilization | |||
| temperature | Sterilization | |||
| Time | Dry Time | Maximum Load | ||
| IUSS | 132C | 3 minutes | 1 minute | Tools - 23 kg |
| Wrapped | 132C | 4 minutes | 20 minutes | Textile -22.2 kg |
| Wrapped Tools - 23 kg | ||||
| IUSS delicate | 121C | 30 minutes | 1 minute | Tools - 23 kg |
| Wrapped delicate | 121C | 30 minutes | 20 minutes | Textile -22.2 kg |
| Wrapped Tools - 23 kg | ||||
| Bowie and Dick | 134C | 3.5 minutes | 2 minutes | N.A |
| Vacuum test | N.A | N.A | N.A | N.A |
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
3
| Model 6690 - All door configurations
Cycle name | Sterilization
temperature | Sterilization
Time | Dry Time | Maximum Load |
|----------------------------------------------------|------------------------------|-----------------------|------------|-------------------------------------------|
| IUSS | 132C | 3 minutes | 1 minute | Tools - 46 kg |
| Wrapped | 132C | 4 minutes | 20 minutes | Textile -33.3 kg
Wrapped Tools - 46 kg |
| IUSS delicate | 121C | 30 minutes | 1 minute | Tools - 46 kg |
| Wrapped delicate | 121C | 30 minutes | 20 minutes | Textile -33.3 kg
Wrapped Tools - 46 kg |
| Bowie and Dick | 134C | 3.5 minutes | 2 minutes | N.A |
| Vacuum test | N.A | N.A | N.A | N.A |
P
:
.
:
14
=
រ
:
.
a l
"
11
ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
| Model 6990 - All door configurations | ||||
|---|---|---|---|---|
| Cycle name | Sterilization | |||
| temperature | Sterilization | |||
| Time | Dry Time | Maximum Load | ||
| IUSS | 132C | 3 minutes | 1 minute | Tools - 46 kg |
| Wrapped | 132C | 4 minutes | 20 minutes | Textile -33.3 kg |
| Wrapped | Wrapped Tools - 46 kg | |||
| IUSS delicate | 121C | 30 minutes | 1 minute | Tools - 46 kg |
| Wrapped delicate | 121C | 30 minutes | 20 minutes | Textile -33.3 kg |
| Wrapped delicate | Wrapped Tools - 46 kg | |||
| Bowie and Dick | 134C | 3.5 minutes | 2 minutes | N.A |
| Vacuum test | N.A | N.A | N.A | N.A |
| Model 66120 - All door configurations | ||||
|---|---|---|---|---|
| Cycle name | Sterilization | |||
| temperature | Sterilization | |||
| Time | Dry Time | Maximum Load | ||
| IUSS | 132C | 3 minutes | 1 minute | Tools - 69 kg |
| Wrapped | 132C | 4 minutes | 20 minutes | Textile -33.3 kg |
| Wrapped Tools - 69 kg | ||||
| IUSS delicate | 121C | 30 minutes | 1 minute | Tools - 69 kg |
| Wrapped delicate | 121C | 30 minutes | 20 minutes | Textile -33.3 kg |
| Wrapped Tools - 69 kg | ||||
| Bowie and Dick | 134C | 3.5 minutes | 2 minutes | N.A |
| Vacuum test | N.A | N.A | N.A | N.A |
4
| Model 69120 - All door configurations | ||||
|---|---|---|---|---|
| Cycle name | Sterilization | |||
| temperature | Sterilization | |||
| Time | Dry Time | Maximum Load | ||
| IUSS | 132C | 3 minutes | 1 minute | Tools - 69 kg |
| Wrapped | 132C | 4 minutes | 20 minutes | Textile -33.3 kg |
| Wrapped Tools - 69 kg | ||||
| IUSS delicate | 121C | 30 minutes | 1 minute | Tools - 69 kg |
| Wrapped delicate | 121C | 30 minutes | 20 minutes | Textile -33.3 kg |
| Wrapped Tools - 69 kg | ||||
| Bowie and Dick | 134C | 3.5 minutes | 2 minutes | N.A |
| Vacuum test | N.A | N.A | N.A | N.A |
| Model 69180 - All door configurations | ||||
|---|---|---|---|---|
| Cycle name | Sterilization | |||
| temperature | Sterilization | |||
| Time | Dry Time | Maximum Load | ||
| IUSS | 132C | 3 minutes | 1 minute | Tools - 92 kg |
| Wrapped | 132C | 4 minutes | 20 minutes | Textile -44.4 kg |
| Wrapped Tools - 92 kg | ||||
| IUSS delicate | 121C | 30 minutes | 1 minute | Tools - 92 kg |
| Wrapped delicate | 121C | 30 minutes | 20 minutes | Textile -44.4 kg |
| Wrapped Tools - 92 kg | ||||
| Bowie and Dick | 134C | 3.5 minutes | 2 minutes | N.A |
| Vacuum test | N.A | N.A | N.A | N.A |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
continue on a separate page if needed.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection is estimated to average 79 hours per response, including the data needed and complete The burden time for this collection is estimated to aronage intinute data needed and complete
time to review instructions, search existences , gather and maintan or any other time to review instructions, search existing data sources, gather and his birden estimate or any other aspect and review the collection of information. Oche some some for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of of conduct of sponsor, and a porcurrently valid OMB number."