Vapocide" is a sterilant solution intended to be used only in the Harvey Chemiclave Sterilizer to sterilize medical and dental surgical instruments and equipment. Vapocide is intended to be a direct substitute for Vapo-Sterli. Vapocide is recomended for use in the following Chemiclave series sterilizer models: Model E, 4000, 5000, 5500, 6000, EM 5000, EM 5500, EM 6000, 6000, 7000, 8000, and in Chemiclave cycle parameters as follows. Model E, 4000, 5000, 5500, 6000, EM 5000, EM 5500, EM 6000, - Operating pressure: 20-40 psi (1.41-2.82 kg/cm²) - Temperature: 132 ± 2°C (270 ± 5°F) - Maximum load: models with 8 and 10 in. diameter chambers Model 7000 and 8000 - Operating pressure: approximately 25 psi - Operating Temperature: 132 + 6, -0°C - Maximum load: 3.3 pounds (1.5 kg) Vapocide is compatible with but not limited to the following material types; - Surgical and cutting instruments, handpieces, and similar items - Plastic materials recommended are: Polysulfone, Phenolic, Epoxy, Polyphenylene, Oxide, Polyester, Polypropylene Vapocide" is not compatible with the following materials: - Linen, textiles or fabrics - Liquids and agars - Items contained in tightly woven packs or wraps - Plastics that cannot tolerate temperature in excess of 132ºC (270ºF) - Nylon tubing & bags inhibit penetration of chemical vapors Vapocide is not recommended for use for "flash" sterilization cycles.

Device Description

Vapocide™ is a liquid sterilant solution designed for use in Harvey Chemiclave sterilizers only. Vapocide™ and the Harvey Chemiclave function as a sustem to sterilize medical and dental surgical instruments and equipment. Vapocide™ is a sterilant solution intended to be used in the Harvey Chemiclave which is a unsaturated chemical vapor sterilizer. Unsaturated chemical vapor sterilizers function by using heat, water, and chemical synergism to sterilize medical and dental equipment. Vapocide™ is made of formaldehyde and ethanol. This formulation when heated under pressure, results in a relatively unsaturated and totally effective sterilization vapor which does not have deleterious effects one mark surfaces.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the Vapocide™ Liquid Chemical Sterilant.

Important Note: The provided document is a 510(k) Summary from 1997. The level of detail regarding acceptance criteria, study design, and statistical analysis is significantly less comprehensive than what would be expected for a modern medical device submission. Many of the specific details requested in your prompt (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, training set details) are simply not present in this type of summary from that era.

Acceptance Criteria and Reported Device Performance for Vapocide™ Liquid Chemical Sterilant

The acceptance criteria for Vapocide™ are primarily based on its performance as a sterilant, specifically its sporicidal effectiveness and material compatibility, when used in conjunction with Harvey Chemiclave Sterilizers. The device aims to demonstrate substantial equivalence to the predicate device, Vapo-Steril.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Implied)	Reported Device Performance (Summary from Document)
Sterilization Effectiveness	Must be sporicidal, effectively killing highly resistant bacterial spores (e.g., Bacillus stearothermophilus). Must achieve sterilization under specified conditions (temperature, pressure, cycle time).	Comparative Testing (Vapocide™ vs. Vapo-Steril): Performed using a modified AOAC Sporicidal Test Protocol. (Details of equivalence not explicitly stated, but implied positive outcome for equivalence claim).AOAC Sporicidal Testing: Demonstrated sporicidal effectiveness of Vapocide™.Simulated Use Testing: Successfully sterilized Bacillus stearothermophilus spores placed on turbines inside dental handpieces in the Chemiclave with Vapocide™. Results confirmed effectiveness under specified conditions.Biological Indicator Evaluation: Confirmed that existing biological indicators are effective for monitoring sterilization with Vapocide™.
Material Compatibility	Must not cause corrosion, pitting, crazing, or cracking on medical/dental instruments upon repeated processing.	Demonstrated material compatibility with various medical and dental instruments (e.g., orthopedic pliers, hand instruments, carbon steel burrs, high-speed handpieces, plastic resin cassettes) after repeated processing, as evaluated by scanning electron microscope and steriomicroscopic equipment. Specific materials not compatible were also identified (linen, liquids, tightly woven packs, plastics unable to tolerate >132ºC, nylon tubing & bags).
Residue / Safety (Formaldehyde)	Must not leave significant or harmful formaldehyde residues on sterilized instruments.	Objective was to determine if formaldehyde residues remained on surfaces after processing with Vapocide™. (Implied acceptable levels, as no negative finding is reported).
Packaging Penetration	Chemical vapors must effectively penetrate typical sterilization packaging.	Demonstrated ability of unsaturated chemical vapors from Vapocide™ to penetrate typical sterilization packaging during the Harvey Chemiclave process.
Toxicity Profile	Must meet safety standards for potential skin irritation, ocular irritation, sensitization, mutagenicity, and acute dermal toxicity.	Skin Irritation: Not a primary dermal irritant in albino rabbits.Ocular Irritation: Produced transient irritation in six rabbits, resolved by 14 days.Sensitization: Did not produce allergenic contact dermatitis in guinea pigs.Mutagenicity: 1% solution did not produce a mutagenic effect in the Ames Spot test.Acute Dermal Toxicity: Dermal LD50 in rabbits considered to be >2 g/kg.
Substantial Equivalence	Must be substantially equivalent in shelf-life, appearance, viscosity, chemical properties (formaldehyde concentration), and microbiology claims to Vapo-Steril.	Shelf-life, Appearance, Viscosity: Both Vapocide™ and Vapo-Steril have a 2-year shelf-life and are clear, colorless liquids. Chemical Properties: Both use formaldehyde (0.23%) and ethanol. Microbiology Claims: Both are sterilants and sporicidal.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated in the summary document for any of the performance tests. The AOAC Sporicidal Test Protocol is a standard method, so its inherent sample sizes would have been followed, but specific numbers are not provided.
- For Simulated Use Testing, it mentions "inoculated dental Handpieces" but no number.
- For Material Compatibility, it lists categories of instruments (e.g., "orthopedic pliers, hand instruments, carbon steel burrs, high speed Handpieces, plastic resin cassettes") but does not quantify the number of items tested within each category or the total.
- For Toxicity Testing:
  - Skin Irritation: Albino rabbits (number not specified, but typically 3-6 for such tests).
  - Ocular Irritation: Six rabbits.
  - Sensitization: Guinea pigs (number not specified).
  - Mutagenicity: Five tester strains of auxotrophic Salmonella typhimurium.
  - Acute Dermal Toxicity: Rabbits (number not specified, but typically 5-10 for LD50 tests).
Data Provenance: The studies were conducted by "Sterilization Technical Services" and "Gibraltar Laboratories." The document doesn't specify countries of origin for these facilities, but given the US FDA submission, it's highly probable these are US-based laboratories. The data appears to be prospective as it describes specific testing performed to evaluate Vapocide™.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The testing was performed by contract laboratories (Sterilization Technical Services, Gibraltar Laboratories). It's assumed their personnel (e.g., microbiologists, toxicologists) established the "ground truth" based on standard protocols, but no specific number or detailed qualifications are provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not specified. This type of device (chemical sterilant) doesn't typically involve human reader adjudication like image analysis AI devices. The "ground truth" for sporicidal efficacy is determined by laboratory culture methods (e.g., absence of growth), and for material compatibility, by visual inspection or microscopy by qualified personnel.

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

MRMC Comparative Effectiveness Study: No. This type of study is irrelevant for a chemical sterilant. MRMC studies are typically used for diagnostic or screening devices where human readers (e.g., radiologists) interpret images or data, and the AI assists in this interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. Vapocide™ is a chemical sterilant, not an algorithm. Its "performance" is inherently "standalone" in the sense that the chemical itself performs the sterilization, with the human component being proper use in the Chemiclave.

7. The Type of Ground Truth Used

The ground truth for the various tests was established through:

Microbiological Culture: For sporicidal effectiveness, the ground truth is the presence or absence of microbial growth after exposure to the sterilant, indicating successful sterilization or failure. This is standard for sterilization validation.
Direct Observation/Microscopy: For material compatibility, the ground truth was visual and microscopic assessment for damage (corrosion, pitting, crazing, cracking).
Chemical Analysis: For residue testing, the ground truth would be quantitative chemical analysis for formaldehyde.
Biological Assays (in vivo/in vitro): For toxicity studies, the ground truth was determined by standardized animal models or in vitro assays (e.g., skin/ocular irritation in rabbits, sensitization in guinea pigs, mutagenicity in bacteria).

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. Vapocide™ is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable. As Vapocide™ is not an AI/ML device, there is no training set or ground truth in that context.

Summary

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K970726

ATTACHMENT 7

510(k) Summary Cottreil, Ltd. Vapocide™ Liquid Chemical Sterilant

BBC 8 1 MAR

Sponsor/Applicant Name 1.

Cottrell, Ltd. 7399 South Tucson Way Englewood, CO 80112 (303) 799-9401 Telephone: (303) 799-9408 Facsimile:

Contact Person

Mr. John Scoville Director of Regulatory Affairs and Quality Assurance

Date of Summary Preparation

February 27, 1997

Device Name 2.

Vapocide™ Proprietary Name: Liquid Chemical Sterilant Common/Usual Name: Liquid Chemical Sterilant Classification Name:

Identification of the predicate or legally marketed device(s) to which 3. equivalence is being claimed

The Cottrell, Ltd. Vapocide™ is substantially equivalent to Vapo-Steril which is manufactured by MDT Biologic Company. The Vapo-Steril solution has been in commercial distribution for as long as the Harvey Chemiclave sterilizer. They are preamendments devices and also are covered under several 510(k) premarket notifications such as K924380 -MDT-Harvey Model 7000 and 8000CHE, and K943654 Harvey Chemiclave EC 5000, 5500, and 6000 MDT Biologic.

2/27/97

Page D --

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4. Device Description

5. Intended Use

Vapocide™ is a sterilant solution intended to be used in the Harvey Chemiclave Sterilizer to sterilize medical and dental surgical instruments and equipment.

6. A statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device(s) cited

Vapocide™ and the predicate Vapo-Steril liquid chemical sterilants are similar with respect to shelf-life, appearance, and viscosity in that they both have a 2 year shelf life and are clear, colorless liquids. Vapocide™ and predicate Vapo-Steril liguid chemical sterilants are similar in chemical properties in that the primary active ingredient in both solution is formaldehyde with ethanol acting synergistically to achieve sterilization. The concentration of formaldehyde in both solutions is 0.23%. Vapocide™ and the predicate Vapo-Steril solutions are similar in * microbiology claims in that they are sterilants and therefore sporicidal.

7. Performance Testing

Performance Testing

Testing was performed to determine the effectiveness of Vapocide™ when used as a liquid chemical sterilant in the Harvey Chemiclave Sterilizer. The tests and results are summarized below:

8 . Conclusion. Based upon all testing summarized above, Vapocide™ is substantially equivalent to May, 1976, for use on the Chemiclave models.

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Comparative testing using Vapocide™ and Vapo-Steril:

Comparison Testing was performed on Vapocide™ and Vapo-Steril using a modified AOAC Sporicidal Test Protocol.

Sporicidal Testing:

AOAC Sporicidal testing was performed by Sterilization Technical Services. This AOAC Sportedal testing was performed of Germinate of determine the sporicidal effectiveness of Vapocide™.

Simulated Use Testing:

ﻧﮯ

Simulated use testing was performed using inoculated dental Handpieces packaged in sterilization pouches processed in the Harvey Chemiclave 8000
Packaged in sterilization pouches processed in the Harvey inc. if Begilly The objective of this suudy was to determine if Bacillus sterilizer. stearothermophilus spores placed on the turbines inside of dental Handpieces in a stedromernophilus spores placed on the tirem. Chemiclave and Vapocide™ liquid chemical sterilant.

Comparison Test for Effectiveness of Vapocide™ and Vapo-Steril:

The purpose of this study was to determine the relative efficacy of Vapocide" The purpose of uns surfy was to assuments, packaging, loading, sterilization process conditions, etc. as well as under half cycle conditions.

Material Compatibility of Vapocide™:

The purpose of this study was to demonstrate material compatibility of Vapocide™ . 4. I he purpose of uns study was to demensions medical and dental instruments, i.e.,
under repeated processing of various medical and dental most Hondrioges orthopedic pliers, hand instruments, carbon steel burrs, high speed Handpieces, plastic resin cassettes. Each of the processed instruments were processed repeatedly using the Harvey Chemiclave and Vapocide™ liquid chemical sterillant repeated for corrosion, pitting, razing, and cracking using the scanning electron microscope and steriomicroscopic equipment.

Cottrell, Ltd. Vapocide™ 510(k)

Page D-3

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Biological Indicator Evaluation:

The purpose of this study was to confirm that the biological indicators currently The purpose of this study was to connini hat the see of Vapocide™ liquid chemical sterilant solution.

Residue Testing:

1- 1-1-1-1

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The objective this testing was to determine if formaldebyde residues remained on The objective this testing was to determine in formand one vapocide™ liquid chemical sterilant solution.

Packaging Evaluation for Sterilant Penetration:

The objective of this testing was to determine the penetration ability of unsaturated
ed the success of the case of the caside through and into typical sterifization The objective of this testing was to users and into typical sterilization
chemical vapors produced from Vapociale™ the survess packaging during the Harvey Chemiclave process.

Toxicity Testing

Toxicity testing was performed on the Vapocide™ liquid chemical sterilant solution Toxicity testing was performed on the vaper mary of the toxicity testing:

Skin Irritation:

This study was performed to determine if exposure to Vapocide™ produces skin This study was performed to Getennine in Gibraltar Laboratories using Vapocide™
irritation. This testing was performed by Gibral 158, 20 . Paragrah C. and albino rabbits according to 40 CFR 158.135 and 158.70, Paragraph C, and albino radones according to 40 -10 -10 -10 -10 -10 -10 -10 -10 -10 -10 -10 -10 -1 Pesticide Assessment Guidenies Subarnistes of this testing showed that the Domestic Annials, Berico serilant is not a primary dermal irritant.

Ocular Irritation:

This study was performed to determine the ocular irritation potential of Vapocide™ This sudy was performed to delamine as a re- - This testing was performed by following instillation in the Cycs in TLSCHER according to 40 CFR

Cottrell, Ltd. Vapocide™ 510(k)

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158.135 and 158.70, Paragraph C, Pesticide Assessment Guidelines Subdivision 1-0.136 Evaluation Human and Domestic Animals, Series 81-4. The results of this testing showed that the Vapocide™ liquid chemical sterilant produced transient irritation in the eyes of six rabbits. This was resolved by 14 days after exposure to Vapocide™.

Sensitization:

This testing was performed to determine the sensitization potential of Vapocide™ This was allergic contact dermatitis in guinea pigs. This testing was performed by Gibraltar Laboratories according to 40 CFR 158.135 and 158.70, Paragraph C, Pesticide Assessment Guidelines Subdivision F: Hazard Evaluation Human and Domestic Animals, Series 81-6, pages 59-62. The results of this testing showed that Vapocide™ did not produce allergenic contact dermatitis following the challenge in guinea pigs.

Mutagenicity:

سب

This testing was performed to determine if Vapocide™ liquid chemical sterilant is mutagenic at the histidine locus in the Salmonella typhimurium strains of Ames. This testing was performed by Gibraltar Laboratories according to the Ames technique. The results of this testing showed that a 1% solution of Vapocide™ did not produce a mutagenic effect in the Ames Spot test employing five tester strains of auxotrophic Salmonella typhimurium.

Acute Dermal Toxicity:

This testing was performed to determine the acute dermal toxicity of Vapocide™ . in rabbits at the dose of two grams per kilogram of body weight. This testing was performed by Gibraltar Laboratories according to 40 CFR 158.135 and 158.70, Paragraph C, Pesticide Assessment Guidelines Subdivision F: Hazard Evaluation Human and Domestic Animals, Series 81-2. The results of this testing showed that the dermal LD50 of Vapocide™ in rabbits was considered to be greater than two grams per kilogram.

2/27/97

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Dolly

Public Health Service

Food and

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Image /page/5/Picture/4 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Cottrell, Ltd C/O Mr. Mark Brown King & Spaulding King & Spadiaiia Avenue, N.W. 1730 Pennsylvania

K970726 Re : Vapocide ™ Unclassified Requlatory Class: Product Code: MED February 23, 1998 Dated: February 23, 1998 Received:

Dear Mr. Brown:

Dear M. Basis.
This letter is written in response to your letter and have and have and This letter is written in response to your leaver and have we have reviewed your appeal of our may is, is an the enclose determined that the indications for use stated in the enclosure) to the equivel (for the indications for use scacea commerce prior to May 20, 1976, the educes marketed in interetate comments, or to devices that development date of the Medical Device with the provisions of the Feberal Food, and Cosmetic Act (Act) . Your my, therefore, and market Food, Drug, and Cosmetic Acontrols provisions of The general controls provisions of the Act include requirements for annual registration, listing of devices, good
requirements and constigo, labeling, and prohibitions against requirements for annual registration, ILSCHigh on
manufacturing practice, labeling, and prohibitions against
and problem and adulteration, manufacturing practicion.

JUN 16 1898

mass to classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be
(Special Controledditional controls. Existing major regulation (Special Controls) or class lif (Prematic Appromations), regulations
subject to such additional controls. Existing major regulations subject to such additional concrors. The Code of Redergal A substantially affecting your device can be 800 to 895.
Regulations, Title 21, Parts 800 to 895. equivalent determination assumes compliance with the Current Good equivalent determination assumes comprisance from in the Quality
Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21)
System Regulation (QS) for Medical Devices: General regulations, the Food System Regulation (QS) for Medical Devices: "General Desire"
CFR Part Regulation (DDA) will verify such assumpions. and Drug Administration (FDA) will verify such assumptions. and Drug Administration (PDA) WITI Verriy Buch as and Failure to comply with the GMP publish further announcements this Please note: action. In addicion, I'm may Federal Register. concerning your device notification submission does not affect any obligation you might have under sections 531 through 542 of the formal any obligation you might have under becoduct Radiation Control
Act for devices the Electronic Productions. Act for devices under the Eisers.
provisions, or other Federal laws or regulations.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance Also, please note the regulation entitled, at (301) 594-4639. "Misbranding by reference to premarket notification" (21 CFR Other general information on your responsibilities under 807.97) . . the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

sincerely yours,

Philip J. Phillips

rector ffice of Device Evaluation enter for Devices and Radiological Health

Enclosure

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ATTACHMENT E

510(k) Number (if known):	K970726
Device Name:	VAPOCIDE TM

Indications For Use:

Vapocide" is a sterilant solution intended to be used only in the Varvey Chemiclave Sterilizer to sterilize medical and dental.
Harvey Chemiclave Sterilizer to sterilize medical and dental. survey Chemics and equipment. Vapocide is intended to be a
survey Chemics and equipment. Vapocide is intended for be a
surgical instruments and equipment. Vapocide is and mor Harroy Chemics and equipment. Vapocide is recomended for use a
direct substitute for Vapo-Sterli. Vapocide is recomended for use a
direct substitute for Vapo-Sterli. Vapocide direct substitute for iclave models:
in the following Chemiclave series steril in the following Chemicrave models. The following tooo, 7000, 7000, 7000, 7000, 8000, 7000, 8000, 8000, 8000, 8000, 8000, 8000,

6000, 7000, 8000, and in Chemiclave cycle parameters as follows.

Model E, 4000, 5000, 5500, 6000, EM 5000, EM 5500, EM 6000,

20-40 psi (1.41-2.82 kg/cm²)
· Operating pressure: · Operating pressure: 20 13222°C (270 ± 5°F)
erature: 13222-C (270 models with
· Maximum load: . Maximum 10ad.
8 and 10 in. diameter chambers

Model 7000 and 8000

approximately 25 psi · Operating pressure:
132 + 6, -0°C · Operating Temperature:
3.3 pounds (1.5 kg) · Maximum load:

Vapocide is compatible with but not limited to the following to
lower and material types; Vapocide 18 compaterial types:

· Surgical and cutting instruments, handpieces, and similar
Polysulfone, Phenolic, items · Plastic materials recommended are:
Plastic materials recommended oxide, Polyester, Polypropylene
Epoxy, Polyphenylene, Oxide, Polyester, Polyestible PolyphenyTene, OxIde, ForyCoccus, College Note:

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

Concurrence of CDRH, office of Device Evaluation (ODE)
(Division Sign-off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K970726

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use

{8}------------------------------------------------

510(k) Number (if known):	K970726
	TM
Device Name:	VAPOCIDE

Indications For Use:

Vapocide" is not compatible with the following materials:

· Linen, textiles or fabrics
Liquids and agars
· Items contained in tightly woven packs or wraps
· Plastics that cannot tolerate temperature in excess of 132ºC (270ºF)
· Nylon tubing & bags inhibit penetration of chemical vapors

Vapocide is not recommended for use for "flash" sterilization cycles.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number	K970726

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

Regulation Number and Section

§ 880.6885 Liquid chemical sterilants/high level disinfectants.

(a)
Identification. A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.(b)
Classification. Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.