Predicate Devices

K/DEN number and list them here in a comma separated list exactly as they appear in the text:
K991418, K060103, K000502

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a chemical indicator card that changes color based on exposure to sterilization processes, with no mention of AI or ML in the description or performance studies.

Therapeutic

No
Explanation: The device is a process indicator for sterilization, not a device used for therapy on a patient.

Diagnostic

No

This device is described as a process indicator that changes color to confirm exposure to sterilization processes, not to diagnose a medical condition in a patient.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical card with indicator ink strips, which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to indicate exposure to sterilization processes (steam and ethylene oxide) by a visual color change. This is a quality control or process monitoring function, not a diagnostic test performed on biological samples to diagnose a disease or condition.
Device Description: The device is a card with indicator ink strips. It does not involve the analysis of biological specimens.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Diagnosis, monitoring, or screening of diseases or conditions
- Use in a laboratory setting for diagnostic purposes

The device is clearly described as a process indicator used to confirm that sterilization parameters have been met. This falls under the category of sterilization process monitoring devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Albert Browne Ltd. VERIFY® STEAM and EO Load Record Card contains process indicators that undergo a visual color change when exposed to steam in a temperature range of 121°C to 135°C (250°F to 275°F) or an ethylene oxide sterilization process.

Product codes

JOJ

Device Description

The proposed VERIFY® STEAM and EO Load Record Card is a 5"x3" card containing space for recording information regarding the load to be processed and two indicator ink strips applied to the card using a rotary screen printing method. The indicator ink strips are steam and ethylene oxide-sensitive indicators that change color following exposure to the appropriate sterilant.

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

Testing was provided in K991418 and K060103 to validate the indicator inksubstrate combinations for use in confirming exposure to ethylene oxide and steam sterilization processes, respectively. Albert Browne Ltd. has performed testing which demonstrates that the indicators perform as intended under in use conditions.

Key Metrics

Not Found

Predicate Device(s)

K991418, K060103, K000502

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

510(k) Summary

AUG 2 5 2006

Albert Browne Ltd. VERIFY® STEAM and EO Load Record Card

1. SUBMITTED BY: Albert Browne Ltd. Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ United Kingdom
  CONTACT PERSON: Richard Bancroft Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ United Kingdom

Telephone: 0116 276 8636

DATE PREPARED: August 10, 2006

DEVICE NAME: 2. VERIFY® STEAM and EO Load Record Card 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 DEVICES

Browne MVI Ethylene Oxide Indicator (K991418) .
Albert Browne, Ltd. VERIFY® STEAM Value Indicators (K060103) ●
Steam/EO Record Card (K000502) ●

1

4. INTENDED USE

The Albert Browne Ltd. VERIFY® STEAM and EO Load Record Card contains process indicators that undergo a visual color change when exposed to steam in a temperature range of 121°C to 135°C (250°F to 275°F) or an ethylene oxide sterilization process.

5. DEVICE DESCRIPTION

The proposed VERIFY® STEAM and EO Load Record Card is a 5"x3" card containing space for recording information regarding the load to be processed and two indicator ink strips applied to the card using a rotary screen printing method. The indicator ink strips are steam and ethylene oxide-sensitive indicators that change color following exposure to the appropriate sterilant.

6. TECHNOLOGICAL CHARACTERISTICS

The indicator inks and substrate used for the manufacture of the proposed VERIFY® STEAM and EO Load Record Card are identical to those described in K991418 and K060103 for the Browne MVI Ethylene Oxide Indicator and Albert Browne, Ltd. VERIFY® STEAM Value Indicators, respectively. The printing process used for application of the indicator inks to the substrate is also identical for the proposed and predicate devices. A tabular comparison of the proposed and predicate devices is provided on the following page.

7. PERFORMANCE TESTING

Testing was provided in K991418 and K060103 to validate the indicator inksubstrate combinations for use in confirming exposure to ethylene oxide and steam sterilization processes, respectively. Albert Browne Ltd. has performed testing which demonstrates that the indicators perform as intended under in use conditions.

2

| Technological
Characteristics | VERIFY®
STEAM and EO Load Card
(proposed) | Browne
MVI Ethylene Oxide Indicator
(K991418) | VERIFY®
STEAM Value Indicators
(K060103) | SteriTec Products, Inc.
Steam/EO Record Card
(K000502) |
|----------------------------------|----------------------------------------------------------------|-----------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|
| Intended Use | | Confirm exposure to a sterilant | Confirm exposure to a sterilant through a visible color change | |
| Sterilization Processes | • Steam
• EO | EO | Steam | • Steam
• EO |
| Color change | • Blue to black (steam)
• Orange to red (EO) | Orange to red | Blue to black | • Blue to black (steam)
• Yellow to brown (EO) |
| Materials of Construction | • Steam and EO-sensitive indicator inks1
• paper substrate2 | • EO-sensitive indicator ink
• paper substrate | • Steam-sensitive indicator ink
• paper substrate | • Steam and EO-sensitive indicator inks
• Unknown substrate |
| Disposable | Yes | Yes | Yes | Yes |
| Sterile | No | No | No | No |

omparison Chart for Determination of Substantial Equivaler

$\underset{O}{\overset{O}{||}}$
Ethylene oxide

The steam and EO-sensitive indicator inks are identical to the inks described and tested in K060103 and K991418.

19 ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

:

3

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is a symbol of medicine and health, and it is often used to represent healthcare organizations. The seal is a symbol of the department's mission to protect the health of all Americans and to provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Albert Browne Limited C/O Dr. Cynthia J. M. Nolte Senior Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

AUG 2 5 2006

Re: K061738

Trade/Device Namc: Albert Browne Ltd. VERIFY STEAM and EO Load Record Card Regulation Number: 880.2800 Regulation Name: Sterilization Process Indication Regulatory Class: II Product Code: JOJ Dated: August 10, 2006 Received: August 11, 2006

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.

4

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 (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 vour 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 (240) 276-0115. 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/industry/support/index.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

5

Indications for Use

510(k) Number (if known): K061738

Device Name: Albert Browne Ltd. VERIFY® STEAM and EO Load Record Card

Indications for Use:

The Albert Browne Ltd. VERIFY® STEAM and EO Load Record Card are process indicators that undergo a visual color change when exposed to steam in a temperature range of 121℃ to 135℃ (250°F to 275°F) or an ethylene oxide sterilization process.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use x (21 CFR 807 Subpart C)

The Course of Children Children Children Children

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shady H. Murphy KD 8/24/01

Anesthesiology, General Hosp. al Control, Dantal Devices

umber: K 061738