(38 days)
The Modified Browne Packaging and Label Steam Process Indicator (Modified Packaging and Label Steam Indicator) is a process indicator which undergoes a visual color change when exposed to steam in a temperature range of 121°C to 135°C (250°F to 275°F).
Like the parent Browne Packaging and Label Steam Indicator, the proposed Modified Packaging and Label Indicator consists of indicator ink applied to a suitable substrate using a flexographic printing method. When exposed to steam in the temperature range of 121°C to 135°C (250°F to 275°F), the indicator changes color. The parent indicator changed color from pink to purple. The color change for the proposed indicator is from pink to dark purple. Neither the proposed or parent indicator is intended to indicate that specific sterilization parameters have been met, but simply that the indicator has been exposed to a steam process.
Here's an analysis of the provided text to extract information about the device's acceptance criteria and the supporting study:
The document describes a "Special 510(K) Summary" for a modified steam process indicator, comparing it to a predicate device. The core of the submission revolves around demonstrating that the modified device performs similarly to or better than the predicate device and meets relevant standards.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Visual color change when exposed to steam | Indicator undergoes a visual color change from pink to dark purple when exposed to steam. |
| Effective temperature range of 121°C to 135°C (250°F to 275°F) | Predicate Device: Indicated a color change in a temperature range of 121°C to 135°C (250°F to 275°F). Modified Device: The effective temperature range was explicitly "expanded to include a 135°C steam sterilization cycle." Performance testing "showed that the indicator performed as designed in 132°C, 134°C, and 135°C sterilization cycles." |
| Conformity to ANSI/AAMI ST60 for Class I process indicators for steam sterilization | Albert Browne Ltd. "performed testing which demonstrates that the Modified Browne Packaging and Label Steam Indicator conform to the applicable requirements of ANSI/AAMI ST60 for Class I process indicators for steam sterilization." |
| Indicator ink compatibility with multiple substrates | The indicator ink composition was modified "to make the ink compatible with multiple substrates," which was a design goal. |
| Improved intensity of visual color change | The indicator ink composition was modified "to improve the intensity of the visual color change." The parent changed from pink to purple, and the proposed changes from pink to dark purple. |
| Chemical reaction for color change is identical to predicate | The chemical reaction that induces the indicator ink to change color is "identical for the parent and proposed indicators." |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size for the test set or the country of origin for the data. It refers to "testing" and "additional testing" performed by Albert Browne Ltd., implying internal validation. Given Albert Browne Ltd. is located in the United Kingdom, it's highly probable the testing was conducted there. The studies appear to be prospective, as they were performed to demonstrate conformity of a newly modified device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth for visual color change interpretation. For a simple visual process indicator, the "ground truth" is likely based on defined color standards (e.g., a specific shade of dark purple indicating success), rather than subjective expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for reviewing test results. For a device with a direct visual output, it's unlikely an adjudication process by multiple readers would be specified unless there were ambiguous color changes, which are not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a simple chemical process indicator, not an AI-powered diagnostic tool. The performance is assessed by its physical color change, not by human interpretation of complex images or data that AI would assist with.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an "algorithm only" performance for an AI device. As this is a chemical process indicator, there is no algorithm involved, and therefore no standalone algorithm performance was conducted. The device's function is entirely chemical and physical.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device is based on physical and chemical properties and compliance with a recognized standard.
- Physical: The device must undergo a visible color change. The document defines the target color change (pink to dark purple).
- Chemical: The underlying chemical reaction for the color change must be identical to the predicate device.
- Standard Compliance: The device must conform to the "applicable requirements of ANSI/AAMI ST60 for Class I process indicators for steam sterilization." This standard itself defines the criteria for what constitutes an effective indicator.
8. The sample size for the training set
This device is not an AI/machine learning device, so there is no training set and therefore no sample size for one.
9. How the ground truth for the training set was established
As there is no training set for an AI/machine learning model, this question is not applicable.
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OCT 1 7 2003
Special 510(K) Summary Albert Browne Ltd. Modified Browne Packaging and Label Steam Process Indicator
- Albert Browne Ltd. 1. SUBMITTED BY: Chancery House 190 Waterside Road Hamilton Industrial Park · Leicester LE5 1QZ United Kingdom
- CONTACT PERSON: Alan Charlton Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ United Kingdom
September 8, 2003 DATE PREPARED:
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Modified Browne Packaging and Label Steam Process 2. DEVICE NAME: Indicator
CLASSIFICATION NAME: Physical/chemical sterilization process indicator -
CLASSIFICATION STATUS: Physical/chemical process indicators are classified as Class II under Sterilization process indicator in 21 CFR 880.2800 (Product Code JOJ) by the General Hospital and Personal Use Devices Panel
3. PREDICATE DEVICE
Browne Packaging and Label Steam Process Indicator (K992767)
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INTENDED USE 4.
The Modified Browne Packaging and Label Steam Process Indicator (Modified Packaging and Label Steam Indicator) is a process indicator which undergoes a visual color change when exposed to steam in a temperature range of 121°C to 135°C (250°F to 275°F).
5. DEVICE DESCRIPTION
Like the parent Browne Packaging and Label Steam Indicator, the proposed Modified Packaging and Label Indicator consists of indicator ink applied to a suitable substrate using a flexographic printing method. When exposed to steam in the temperature range of 121°C to 135°C (250°F to 275°F), the indicator changes color. The parent indicator changed color from pink to purple. The color change for the proposed indicator is from pink to dark purple. Neither the proposed or parent indicator is intended to indicate that specific sterilization parameters have been met, but simply that the indicator has been exposed to a steam process.
TECHNOLOGICAL CHARACTERISTICS 6.
The technological characteristics of the proposed Modified Packaging and Label Steam Indicator and the parent indicator are identical. The proposed and predicate devices consist of indicator ink applied to a substrate. The indicator ink changes color to confirm exposure to steam.
The Modified Packaging and Label Steam Indicator consists of indicator ink applied using a flexographic printing method to packaging material, self-adhesive labels, tapes, tags, inserts, etc. The indicator ink composition for the proposed Modified Packaging and Label Indicator was modified to make the ink compatible with multiple substrates and improve the intensity of the visual color change.
The substrates used to support the indicator ink are identical for the proposed and predicate devices. The substrates for both the proposed and parent indicators are clay-coated label stock (some containing permanent or peelable adhesive and a siliconized backing) and steam-sterilizable paper.
The composition of the indicator ink used for the proposed Modified Packaging and Label Indicator was modified to make the ink compatible with multiple substrates and increase the intensity of the color change. The chemical reaction that induces the indicator ink to change color is identical for the parent and proposed indicators. The
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effective temperature range of the proposed device was expanded to include a 135°C steam sterilization cycle.
7. PERFORMANCE TESTING
Albert Browne Ltd. has performed testing which demonstrates that the Modified Browne Packaging and Label Steam Indicator conform to the applicable requirements of ANSI/AAMI ST60 for Class I process indicators for steam sterilization. Additional testing showed that the indicator performed as designed in 132°C, 134°C, and 135°C sterilization cycles.
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Image /page/3/Picture/1 description: The image is a circular seal for the U.S. Department of Health & Human Services. The seal features the department's name encircling an emblem. The emblem is a stylized eagle with its wings spread, symbolizing protection and service. The overall design is simple and professional, reflecting the department's role in public health and welfare.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 7 2003
Albert Browne Limited C/O Dr. Cynthia J.M. Nolte Ph.D. Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K032801
Trade/Device Name: Modified Browne Packaging and Label Steam Process Indicator Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: September 8, 2003 Received: September 22, 2003
Dear Dr. Nolte:
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.
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Page 2 -Dr. Nolte
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 (OS) 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 vours.
Susan Runnerfz
Chip Line, Ph.D.
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
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KO32801
510(k) Number (if known):
Device Name: Modified Browne Packaging and Label Steam Process Indicator
Indications for Use:
The Modified Browne Packaging and Label Steam Process Indicator is a process indicator which undergoes a visual color change when exposed to steam in a temperature range of 121°C to 135°C (250°F to 275°F).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pat. Atty. Steven Spencer Chang, Inc., 10/17/03
(Division Sign-Off) Division of Anesthesiology, General Hospital, n Control. Dental
510(k) Number: F-032801
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
Albert Browne Ltd. Special 510(k) Modified Packaging and Label Steam Indicator September 8, 2003
§ 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).