Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on a physical process challenge device and chemical indicator, with no mention of software, algorithms, or data processing that would suggest AI/ML.

Therapeutic

No
This device is a process challenge test device used to test the effectiveness of steam sterilizers, not a device directly used for therapy or treatment on a patient.

Diagnostic

No

Explanation: The device is a process challenge test device used to confirm steam sterilizer performance, not to diagnose a medical condition in a patient.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components: a capsule, removable cap, sample holder, and a lumen. It also mentions an "integrator display" which is a physical component. The testing involves placing the device in a steam sterilizer and examining physical indicators.

IVD (In Vitro Diagnostic)

Based on the provided information, the Propper Vapor Line PCD is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states it is for "routine challenge testing steam sterilizers". This is a diagnostic process to determine if the sterilization equipment is functioning correctly.
Device Description: It is a "process challenge test device". This type of device is used to evaluate the effectiveness of a process (in this case, sterilization).
Performance Studies: The performance studies involve comparing the device's results to biological indicators (Duo-Spore and BI-OK), which are used to assess the lethality of the sterilization process. The metrics measured (% Survived, % Fail) are indicative of a diagnostic test's performance.

While it doesn't directly test a patient sample, it is used to diagnose the performance of a medical device (the sterilizer) that is critical for patient safety. This falls under the scope of IVDs, which include devices used to examine specimens derived from the human body or to provide information about a physiological state, pathological state, or congenital abnormality, or to determine the safety and efficacy of a medical device. In this case, it's providing information about the efficacy of the sterilization process.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Propper Vapor Line PCD is indicated for use in routine challenge testing steam sterilizers in pre-vacuum cycles operating at 273.2°F/134°C.

Product codes (comma separated list FDA assigned to the subject device)

JOJ

Device Description

Propper Vapor Line PCD is a process challenge test device for use in pre-vacuum steam sterilization processes at 273.2°F/134°C. It consists of a capsule with a removable cap and sample holder to permit the positioning and removal of the Propper Vapor Line Integrator. One end of the capsule is connected to a lumen. During the sterilization cycle, the open end of the lumen permits residual air to exit and steam to enter the capsule The integrator display will indicate whether or not sterilization conditions were attained inside the metal capsule. The Propper Vapor Line PCD and Propper Bio-Challenge Test-Pak are both Steam Process Challenge test devices designed for use in steam sterilization processes. They are similar in function but differ in design and construction. The challenge to steam penetration presented by the Propper Vapor Line PCD is controlled by the length, bore and configuration of the lumen which is the only opening into the capsule.

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

The safety and effectiveness of the Propper Vapor Line PCD Steam Sterilization Process Challenge Test were determined by comparing the performance characteristics of this device directly to that of the Propper Bio-Challenge Test-Pak in side-by-side testing in a steam sterilizer. Before each test cycle, a Propper Vapor Line Integrator was placed into the slot of the PCD sample holder which was then inserted into the body of the metal capsule and secured in position with the screw cap. The PCD device was placed inside the sterilizer chamber on the lower rack over the drain, side-by-side with two Propper Bio-Challenge Test-Paks. One pack contained a Duo-Spore indicator and the other a BI-OK indicator. Then, a conventional 4-pulse pre-vacuum steam sterilization cycle was run. Cycle tests were run at 273.2°F/134°C for different exposure times. After each sterilization cycle, the Vapor Line integrator was retrieved and examined to determine the “PASS” or “FAIL” reading. The Duo-Spore strip was aseptically removed from its glassine envelope, transferred to trypticase soy broth and incubated at 56°C. The spore strip was examined for growth on a daily basis for seven days. The BI-OK vial was activated, incubated at 56°C for 48 hours and then examined for growth. A second sterilizer study was conducted to establish multiple device equivalency.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Nonclinical Tests: The safety and effectiveness of the Propper Vapor Line PCD Steam Sterilization Process Challenge Test were determined by comparing the performance characteristics of this device directly to that of the Propper Bio-Challenge Test-Pak in side-by-side testing in a steam sterilizer. Before each test cycle, a Propper Vapor Line Integrator was placed into the slot of the PCD sample holder which was then inserted into the body of the metal capsule and secured in position with the screw cap. The PCD device was placed inside the sterilizer chamber on the lower rack over the drain, side-by-side with two Propper Bio-Challenge Test-Paks. One pack contained a Duo-Spore indicator and the other a BI-OK indicator. Then, a conventional 4-pulse pre-vacuum steam sterilization cycle was run. Cycle tests were run at 273.2°F/134°C for different exposure times. After each sterilization cycle, the Vapor Line integrator was retrieved and examined to determine the “PASS” or “FAIL” reading. The Duo-Spore strip was aseptically removed from its glassine envelope, transferred to trypticase soy broth and incubated at 56°C. The spore strip was examined for growth on a daily basis for seven days. The BI-OK vial was activated, incubated at 56°C for 48 hours and then examined for growth. A second sterilizer study was conducted to establish multiple device equivalency. Complete test results appear in tabular form at the end of this summary.

VAPOR LINE PCD vs BIO-CHALLENGE TEST-PAK Exposure Time vs % Fail/Survival
Temperature @ 273.2F(134C)
Exposure Time (min.): 0.25, 0.60, 1.00, 1.50, 1.75, 2.00
% Survived (Duo-Spore)*: 0, 0, 0, 0, 0, 0
% Survived (BI-O.K.): 80, 40, 0, 0, 0, 0
% Fail (Propper Vapor Line PCD): 100, 100, 100, 100, 15, 0
Total No. of Tests: 5, 20, 20, 5, 20, 20

Complete spore death occurred prior to 0.25 minutes exposure

PROPPER VAPOR LINE PCD MULTIPLE DEVICE EQUIVALENCY STUDY
Temperature @ 273.2F/134C
Exposure Time (min.): 1.50, 1.75, 2.00
1.50 (Fail/Total): PCD 1* (1/1), PCD 2 (1/1), PCD 3 (1/1), PCD 4 (1/1), PCD 5 (1/1)
1.75 (Fail/Total): PCD 1* (3/6), PCD 2 (4/6), PCD 3 (3/6), PCD 4 (2/6), PCD 5 (2/6)
2.00 (Fail/Total): PCD 1* (0/6), PCD 2 (0/6), PCD 3 (0/6), PCD 4 (0/6), PCD 5 (0/6)
% FAIL (Vapor Line PCD): 1.50 (100), 1.75 (47), 2.00 (0)
Total Number of Tests: 1.50 (5), 1.75 (30), 2.00 (30)

PCD # I also used in comparative testing vs Bio-Challenge Test Pak

Test Conclusions: The Propper Vapor Line PCD is a highly reproducible challenge test. It will not indicate acceptable “PASS” results until after complete spore death has occurred. Based on the performance data, the test is safe and effective for its intended use. It is substantially equivalent in performance to commercial biological challenge tests used in pre-vacuum steam sterilizer cycle testing.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Key metrics include %Survived (for predicate devices) and %Fail (for subject device) for various exposure times.

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.

Propper Bio-Challenge Test-Pak

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

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

AUG 1 7 2004

510(k) SUMMARY

Propper Vapor Line PCD Steam Sterilization Process Challenge Test 510(k) Number: K031152

| Submitter Information: | Propper Manufacturing Co., Inc.
36-04 Skillman Avenue
Long Island City, NY 11101
Attn: Frank E. Platko, Ph.D.
Telephone: (718) 392-6650 Ext. 264 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | (Trade:) Propper Vapor Line PCD Steam Sterilization Process Challenge Test
(Common:) Steam Chemical Indicator
(Classification:) Physical/Chemical Sterilization Process Indicator |
| Substantial Equivalence
Device: | Propper Bio-Challenge Test-Pak |
| Device Description: | Propper Vapor Line PCD is a process challenge test device for use in pre-
vacuum steam sterilization processes at 273.2°F/134°C. It consists of a
capsule with a removable cap and sample holder to permit the positioning
and removal of the Propper Vapor Line Integrator. One end of the capsule
is connected to a lumen. During the sterilization cycle, the open end of the
lumen permits residual air to exit and steam to enter the capsule The
integrator display will indicate whether or not sterilization conditions were
attained inside the metal capsule. |
| Intended Use
Of Device: | The Propper Vapor Line PCD is indicated for use in routine challenge
testing steam sterilizers in pre-vacuum cycles operating at 273.2°F/134°C. |
| Technological
Characteristics: | The Propper Vapor Line PCD and Propper Bio-Challenge Test-Pak are
both Steam Process Challenge test devices designed for use in steam
sterilization processes. They are similar in function but differ in design
and construction. |
| | The challenge to steam penetration presented by the Propper Vapor Line
PCD is controlled by the length, bore and configuration of the lumen
which is the only opening into the capsule. Whereas the corresponding |

1

510(k) Summary---continued

:

	challenge by the Propper Bio-Challenge Test-Pak is determined by a steam-resistant paper load and a rate controlling barrier film.
Nonclinical
Tests:	The safety and effectiveness of the Propper Vapor Line PCD Steam Sterilization Process Challenge Test were determined by comparing the performance characteristics of this device directly to that of the Propper Bio-Challenge Test-Pak in side-by-side testing in a steam sterilizer.
Before each test cycle, a Propper Vapor Line Integrator was placed into the slot of the PCD sample holder which was then inserted into the body of the metal capsule and secured in position with the screw cap. The PCD device was placed inside the sterilizer chamber on the lower rack over the drain, side-by-side with two Propper Bio-Challenge Test-Paks. One pack contained a Duo-Spore indicator and the other a BI-OK indicator. Then, a conventional 4-pulse pre-vacuum steam sterilization cycle was run. Cycle tests were run at 273.2°F/134°C for different exposure times.
After each sterilization cycle, the Vapor Line integrator was retrieved and examined to determine the “PASS” or “FAIL” reading. The Duo-Spore strip was aseptically removed from its glassine envelope, transferred to trypticase soy broth and incubated at 56°C. The spore strip was examined for growth on a daily basis for seven days. The BI-OK vial was activated, incubated at 56°C for 48 hours and then examined for growth. A second sterilizer study was conducted to establish multiple device equivalency. Complete test results appear in tabular form at the end of this summary
Test
Conclusions:	The Propper Vapor Line PCD is a highly reproducible challenge test. It will not indicate acceptable “PASS” results until after complete spore death has occurred. Based on the performance data, the test is safe and effective for its intended use. It is substantially equivalent in performance to commercial biological challenge tests used in pre-vacuum steam sterilizer cycle testing.

2

VAPOR LINE PCD vs BIO-CHALLENGE TEST-PAK Exposure Time vs % Fail/Survival

273.2F(134C)
Exposure Time (min.)	0.25	0.60	1.00	1.50	1.75	2.00
% Survived (Duo-Spore)*	0	0	0	0	0	0
% Survived (BI-O.K.)	80	40	0	0	0	0
% Fail (Propper Vapor Line PCD)	100	100	100	100	15	0
Total No. of Tests	5	20	20	5	20	20

Complete spore death occurred prior to 0.25 minutes exposure

3

PROPPER VAPOR LINE PCD MULTIPLE DEVICE EQUIVALENCY STUDY

Temperature @ 273.2F/134C

Exposure Time (min.)	1.50	1.75	2.00
	Fail/Total	Fail/Total	Fail/Total
PCD 1*	1/1	3/6	0/6
PCD 2	1/1	4/6	0/6
PCD 3	1/1	3/6	0/6
PCD 4	1/1	2/6	0/6
PCD 5	1/1	2/6	0/6
% FAIL (Vapor Line PCD)	100	47	0
Total Number of Tests	5	30	30

PCD # I also used in comparative testing vs Bio-Challenge Test Pak

4

Image /page/4/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 7 2004

Dr. John D. Dyckman Vice President, Research and Development Propper Manufacturing Company, Incorporated 36-04 Skillman Avenue Long Island City, New York 11101

Re: K031152

Trade/Device Name: Propper Vapor Line PCD Steam Sterilization Process Challenge Test Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: May 28, 2004 Received: June 2, 2004

Dear Dr. Dyckman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your end have determined the device is substantially equivalent (for the recroniced above and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinons, or to arretic Act (Act) that do not require approval of a premarket the Federal F 60a; Drag). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents of a 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 (1 Nr.), it may of such to back of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

5

Page 2 - Dr. Dyckman

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 and ifements 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,

Ques

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

6

K031152 510(k) Number (if known):_

Device Name: Propper Vapor Line PCD Steam Sterilization Process Challenge Test

Indications For Use:

The PROPPER VAPOR LINE PCD is indicated for use as a routine process challenge test for steam sterilizers in pre-vacuum cycles at 273.2°F/134°C.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kai Murray

(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental

510(k) Number: K031152

Prescription Use (Pcr 21 CFR 801.109) OR

Over-The-Counter Use X

(Optional Formal 1-2-96)