(10 days)
Not Found
No
The device is a biological indicator for sterilization monitoring, which relies on the growth of bacterial spores, not AI/ML algorithms. The summary explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
This device is designed to monitor the effectiveness of sterilizers, not to treat or diagnose medical conditions in patients. #
No
The device is designed to monitor chemical vapor sterilizers by using bacterial spore strips to validate sterilization processes, not to diagnose medical conditions in patients.
No
The device description clearly states it is a physical spore strip inoculated with bacterial spores, which is a hardware component, not software.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is designed to "monitor Chemiclave® chemical vapor sterilizers." This monitoring is done by assessing the viability of bacterial spores after exposure to the sterilization process. This is a test performed in vitro (outside of a living organism) to evaluate the effectiveness of a process.
- Device Description: The device contains bacterial spores and is used in conjunction with a "SporView Culture Media (Tryptic Soy Broth, Modified with Bromocresol Purple)." The culture media is used to grow any surviving spores, which is a classic in vitro diagnostic technique to determine the presence and viability of microorganisms.
- Performance Studies: The testing described involves incubating the spore strips in culture media and observing the results (presumably growth or no growth). This is a diagnostic test to determine if the sterilization process was successful.
While the device itself is a spore strip, its intended use and the method of evaluation (culturing in media) clearly fall under the definition of an In Vitro Diagnostic device, as it is used to perform a test outside of the body to provide information about the effectiveness of a process.
N/A
Intended Use / Indications for Use
The SPSmedical SporView® Bacterial Spore Strip is designed for routine monitoring of Steam, Dry Heat, EO Gas, and Chemiclave® sterilization processes. The indicator should be placed in the most difficult to sterilize location of the Chemiclave® sterilization load. The spore strip is aseptically transferred into SPSmedical's SporView® Culture Media (Tryptic Soy Broth with Bromocresol Purple) and incubated at 60 C. The combination of SPSmedical's spore strip and media has been validated for a reduced incubation time of 72 hours for the Chemiclave® chemical vapor sterilization process.
The SPSmedical SportView® Bacterial Spore Strip is designed to monitor Chemiclave® chemical vapor sterilizers. The combination of SPSmedical's spore strip and SporView Culture Media (Tryptic Soy Broth, Modified with Bromocresol Purple) has been validated at 60 ℃ for a reduced incubation time of 72 hours for the Chemical vapor sterilization process.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
The SPSmedical SporView® Bacterial Spore Strip is inoculated with either Geobacillus stearothermophilus ATCC# 7953 or Bacillus atrophaeus ATTC# 9372 bacterial spores. A dual species spore strip containing both the Geobacillus stearothermophilus ATCC# 7953 and Bacillus atrophaeus ATTC# 9372 organisms is also manufactured. The strip is packaged in a blue, glassine envelope.
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)
Testing was conducted following the FDA guidance for the validation of reduced incubation of biological indicators. Testing was performed for the Chemiclave® chemical vapor sterilization process using three lots of biological indicators; this included a newly manufactured lot, mid-range expiration lot and a lot nearing its expiration date. All lots were tested using SPSmedical's SporView® Culture Media (Tryptic Soy Broth, Modified with Bromocresol Purple). All lots tested resulted in a 72 hour reduced incubation time for the chemical vapor sterilization process when using the combination of the SPSmedical SporView® Bacterial Spore Strip and the SPSmedical's SporView® Culture Media.
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
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).
0
MAY - 6 2004
510(k) Summary of Safety and Effectiveness
Submitter:
- SPSmedical Supply Corp. . 6789 West Henrietta Road Rush, NY 14543 U.S.A. Phone: (585)-359-0130 Fax: (585)-359-0167
- Establishment FDA Registration No.: 1319130 .
- Date Summary was Prepared April 2181, 2004 .
- Gary J. Socola . Printed name of person submitting for 510(k)
- Me Dote ● Signature of befson submitting for 510(k)
- Director of Quality Assurance � Title of person submitting for 510(k)
Device Name and Classification
| Trade Name: | SPSmedical SporView® Bacterial Spore Strip |
|---|---|
| Classification Name: | Sterilization Process Biological Indicator |
| Common Name: | Spore Strip Biological Indicator |
| Device Classification: | Class II, Regulation Number 880.2800 |
| Product Code: | FRC |
| Predicate Device: | SPSmedical SporView® Bacterial Spore Strip K023716 |
| K905425 |
1
Device Description:
The SPSmedical SporView® Bacterial Spore Strip is inoculated with either Geobacillus stearothermophilus ATCC# 7953 or Bacillus atrophaeus ATTC# 9372 bacterial spores. A dual species spore strip containing both the Geobacillus stearothermophilus ATCC# 7953 and Bacillus atrophaeus ATTC# 9372 organisms is also manufactured. The strip is packaged in a blue, glassine envelope.
Intended Use:
The SPSmedical SporView® Bacterial Spore Strip is designed for routine monitoring of Steam, Dry Heat, EO Gas, and Chemiclave® sterilization processes. The indicator should be placed in the most difficult to sterilize location of the Chemiclave® sterilization load. The spore strip is aseptically transferred into SPSmedical's SporView® Culture Media (Tryptic Soy Broth with Bromocresol Purple) and incubated at 60 C. The combination of SPSmedical's spore strip and media has been validated for a reduced incubation time of 72 hours for the Chemiclave® chemical vapor sterilization process.
Statement of Similarity to the Legally Marketed Predicate Device:
- . Have the same indicated use
- Incorporate the same materials .
- . Have the same shelf life
- Packaged using the same materials and processes .
Non-Clinical Testing:
Testing was conducted following the FDA guidance for the validation of reduced incubation of biological indicators. Testing was performed for the Chemiclave® chemical vapor sterilization process using three lots of biological indicators; this included a newly manufactured lot, mid-range expiration lot and a lot nearing its expiration date. All lots were tested using SPSmedical's SporView® Culture Media (Tryptic Soy Broth, Modified with Bromocresol Purple). All lots tested resulted in a 72 hour reduced incubation time for the chemical vapor sterilization process when using the combination of the SPSmedical SporView® Bacterial Spore Strip and the SPSmedical's SporView® Culture Media.
Conclusion:
Supportive data has demonstrated that the SPSmedical SporView® Bacterial Spore Strip is equivalent to the legally marketed predicate device. Results of performance testing validate that the SPSmedical SporView® Bacterial Spore Strip provides a 72 hour reduced incubation time when used with the SPSmedical SporView® Culture Media in monitoring the Chemiclave® chemical vapor sterilization process.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing or feather shapes.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 6 2004
Mr. Gary J. Socola Director of Quality Assurance & Sterilization Projects SPSmedical Supply Corporation 6789 West Henrietta Road Rush, New York 14543
Re: K041099
Trade/Device Name: SPSmedical SporView® Bacterial Spore Strip Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: April 21, 2004 Received: April 26, 2004
Dear Mr. Socola:
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.
3
Page 2 - Mr. Socola
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,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS for USE STATEMENT
510(k) Number (if known): _ K04) 099
Device Name: SPSmedical SporView® Bacterial Spore Strip
Indications For Use:
The SPSmedical SportView® Bacterial Spore Strip is designed to monitor Chemiclave® chemical vapor sterilizers. The combination of SPSmedical's spore strip and SporView Culture Media (Tryptic Soy Broth, Modified with Bromocresol Purple) has been validated at 60 ℃ for a reduced incubation time of 72 hours for the Chemical vapor sterilization process.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kei Mulay
(Division Sian-Off Division of Anesthesiology. General Hospital. Infection Control, Dental De
510(k) Number: K 041099