(26 days)
Pre-amendment device
Not Found
No
The device description and performance studies focus on a biological indicator (spore strip) and its associated growth medium for testing sterilization efficacy. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of these technologies.
No
The device is described as a bacterial spore strip intended for testing the efficacy of steam sterilization cycles, not for treating or diagnosing any medical condition in patients.
No
The device is intended for testing the efficacy of steam sterilization cycles, not for diagnosing a condition in a patient.
No
The device description clearly states it is a physical spore strip made of cotton paper filter inoculated with bacterial spores, packaged in a glassine pouch. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to test the efficacy of Steam sterilization cycles. This is a quality control measure for sterilization equipment, not a diagnostic test performed on a biological sample from a patient to diagnose a disease or condition.
- Device Description: The device is a spore strip used to challenge a sterilization process. It does not interact with a patient's biological sample for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any characteristics typical of an IVD, such as analyzing patient samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis, treatment, or monitoring of a patient's health.
This device falls under the category of a sterilization process indicator, specifically a biological indicator. These are used to verify that a sterilization process has been effective in killing microorganisms.
N/A
Intended Use / Indications for Use
The Raven Bacterial Spore Strip (single species B. stearothermophilus ATCC#7953 or dual species B. stearothermophilus ATCC #7953 and B. subtilis ATCC #9372) is intended for use in testing the efficacy of Steam sterilization cycles at 121°C . A reduced incubation time of 48 hours at 55-60℃ has been validated for Steam sterilization when the Raven Bacterial Spore Strip (either the single species B. stearothermophilus spore strip or the dual species spore strip) is used in conjunction with Raven's Modified Tryptic Soy Broth with Bromocresol Purple.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
Raven Bacterial Spore Strip is a 1.5" x 0.25" Schleicher and Schuell #470 cotton paper filter spore strip inoculated with either single species (B. stearothermophilus ATCC #7953) or dual species (B. stearothermophilus ATCC #7953 and B. subtilis ATCC #19372) bacterial spores. The strip is packaged in a #30 blue glassine peel open pouch.
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)
Per FDA guidance for validation of reduced incubation of biological indicators, testing Performed for the Steam sterilization process using three lots each of newly was performed for the Gloum Stelliar nearing expiry, newly manufactured Modified manufactured spore strips, opere stipe neal MTSB w/ BCP) and MTSB w/ BCP nearing rryptic Soy Broth with Bromovious i upic (w and media was tested. For all explity. Each Combination of new and noal Siphy sterilization was demonstrated when fols lested, 40 hour reddod in conjunction with Raven's Modified Tryptic Soy Broth with Bromocresol Purple.
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.
Pre-amendment device
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
K 020026
SUMMARY OF RAVEN BACTERIAL SPORE STRIPS
JAN 3 0 2002
| Submitter: | Raven Biological Laboratories, Inc.
8607 Park Drive
Omaha, NE 68127
(402) 593-0781
(402) 593-0921 Fax |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Contact: | Robert Dwyer
President |
| | Wendy Royalty-Hann
Quality Assurance/Regulatory Affairs Manager |
| Prepared on: | January 2, 2002 |
| Device name: | Raven Bacterial Spore Strip |
| Classification: | Class II medical device, General hospital |
| Predicate Devices (legally marketed): | Raven Bacterial Spore Strip |
| Predicate Device 510(k) number: | Pre-amendment device |
Description:
Raven Bacterial Spore Strip is a 1.5" x 0.25" Schleicher and Schuell #470 cotton paper filter spore strip inoculated with either single species (B. stearothermophilus ATCC #7953) or dual species (B. stearothermophilus ATCC #7953 and B. subtilis ATCC #19372) bacterial spores. The strip is packaged in a #30 blue glassine peel open pouch.
Operational Principles:
The bacterial spore strip is exposed in the glassine pouch to a Steam sterilization cycle rice baotenairepens B. stearothermophilus or dual species. The spore strip is intended for (Single Spooler D. Stourother of the sterilization process and should be placed in the use in determining the onealy the load. Upon cycle completion, the spore strip should most unficult to stomics and aseptically transferred into an appropriate growth media. The media should then be incubated at 55-60°C. Media should be monitored daily for growth and results recorded. When used in conjunction with Raven's Modified Tryptic g row aroth with Bromocresol Purple, a reduced incubation time for Steam has been validated at 48 hours. Growth will be indicated by a change in color from purple to/towards yellow and/or by turbidity. Detection of a failed sterilization cycle is facilitated by the use of the Raven Bacterial Spore Strip.
1
Statement of Similarity to Legally Marketed Predicate Device
The Raven Bacterial Spore Strip has the following similarities to the legally marketed Pre-amendment Raven Bacterial Spore Strip.
- Have the same indicated use
- Incorporate the same materials
- Have the same shelf life, and
- Are packaged using the same materials and processes.
Description of Testing:
Per FDA guidance for validation of reduced incubation of biological indicators, testing Performed for the Steam sterilization process using three lots each of newly was performed for the Gloum Stelliar nearing expiry, newly manufactured Modified manufactured spore strips, opere stipe neal MTSB w/ BCP) and MTSB w/ BCP nearing rryptic Soy Broth with Bromovious i upic (w and media was tested. For all explity. Each Combination of new and noal Siphy sterilization was demonstrated when fols lested, 40 hour reddod in conjunction with Raven's Modified Tryptic Soy Broth with Bromocresol Purple.
Conclusion
The Raven Bacterial Spore Strip is substantially equivalent in composition and function The Raven Dacterial Opero Only is Suice, Pre-amendment Raven Bacterial Spore Strip, to the Legally Manicitou produced creduced incubation period of 48 hours for montoning Occam Stormization of Systems Modified Tryptic Soy Broth with Bromocresol Purple.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2002
Ms. Wendy Royalty-Hann QA/RA Manager Raven Biological Laboratories, Incorporated 8607 Park Drive Omaha, Nebraska 68127
Re: K020026
Trade/Device Name: Raven Bacterial Spore Strips for Steam Sterilization Regulation Number: 880.2800 Regulation Name: Biological Indicators Regulatory Class: II Product Code: FRC Dated: January 23, 2002 Received: January 4, 2002
Dear Ms. Hann:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nate fortened your and have determined the device is substantially equivalent (for the indications
muleations
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sales in the encreases , 15 the enactment date of the Medical Device Amendments, commerce pror to may as nay lassified in accordance with the provisions of the Federal or to devices and Cosmetic Act (Act) that do not require approval of a premarket approval 1 000, Brug, and Connectore, market the device, subject to the general controls application (1 Mr.) - 1 ou experal controls provisions of the Act include requirements for provisions of ation, 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 (1 will), it indy of budget of Federal Regulations, Title 21, Parts 800 to 898. In your device anay 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
3
Page 2 - Ms. Hann
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I edelar statues and registereds, including, but not limited to: registration 1 ou must comply with and Hovering (21 CFR Part 801); good manufacturing practice alla listing (21 CFR Part 807), laceling (21 CFR Pat 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 This icity will and w you to began interest of substantial equivalence of your device to 310(K) premarket notification. I rice 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 If you desire specific at not 2017 your in vitro diagnostic devices), please contact the allo auditionally 21 OF N 2 at 1 and 1 and 1 and tionally, for questions on the promotion and Office of Comphance at (e please contact the Office of Compliance at (301) 594-4639. ad veraling or your working entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under nother in the relation of Small Manufacturers, International and the Act may be obtained from the enumber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Timothy A. Ulatowski
A. Ulatowski Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Attachment 2
Indications for Use Statement
510(k) Number K020026
Number
Device Name Raven Bacterial Spore Strips
The Raven Bacterial Spore Strip (single species B. Indications for stearothermophilus ATCC#7953 or dual species B. Use stearothermophilus ATCC #7953 and B. subtilis ATCC #9372) is intended for use in testing the efficacy of Steam sterilization cycles at 121°C . A reduced incubation time of 48 hours at 55-60℃ has been validated for Steam sterilization when the Raven Bacterial Spore Strip (either the single species B. stearothermophilus spore strip or the dual species spore strip) is used in conjunction with Raven's Modified Tryptic Soy Broth with Bromocresol Purple.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Olin S. Lahn
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K020026