(444 days)
Not Found
No
The document describes a chemical sterilant solution and its use in a specific type of sterilizer. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device, Vapocide™, is a sterilant solution used to sterilize medical and dental instruments, not to treat a disease or condition in a patient.
No
The device, Vapocide™, is a sterilant solution used to sterilize medical and dental surgical instruments, not to diagnose a condition or disease.
No
The device description clearly states that Vapocide™ is a liquid sterilant solution, which is a chemical substance, not software. The 510(k) summary describes performance testing related to the chemical properties and effectiveness of the solution.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to sterilize medical and dental surgical instruments and equipment. This is a process applied to devices used in medical procedures, not a test performed on biological samples to diagnose a condition.
- Device Description: The device is a liquid sterilant solution used in a sterilizer. It functions by using heat, water, and chemicals to kill microorganisms on instruments. This is a sterilization process, not a diagnostic test.
- Performance Studies: The performance studies focus on the effectiveness of the sterilant in killing microorganisms (sporicidal testing, simulated use testing) and its compatibility with materials. These are relevant to sterilization efficacy and safety, not diagnostic accuracy.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (proteins, DNA, antibodies, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is clearly intended for the sterilization of medical instruments, which falls under the category of a medical device used in the healthcare setting, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Vapocide™ is a sterilant solution intended to be used in the Harvey Chemiclave Sterilizer to sterilize medical and dental surgical instruments and equipment.
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-Steril. Vapocide™ is recommended for use in the following Chemiclave series sterilizer models: Model E, 4000, 5000, 5500, 6000, EM 5000, EM 5500, EM 6000, 7000, and 8000.
Recommended Chemiclave cycle parameters:
Model E, 4000, 5000, 5500, 6000, EM 5000, EM 5500, EM 6000:
- Operating pressure: 20-40 psi (1.41-2.82 kg/cm²)
- Operating temperature: 132±2°C (270±5°F)
- Maximum load: 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 132°C (270°F)
- Nylon tubing & bags inhibit penetration of chemical vapors
Vapocide™ is not recommended for use for "flash" sterilization cycles.
Product codes (comma separated list FDA assigned to the subject device)
MED
Device Description
Vapocide™ is a liquid sterilant solution designed for use in Harvey Chemiclave sterilizers only. Vapocide™ and the Harvey Chemiclave function as a system 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.
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)
Performance Testing:
Testing was performed to determine the effectiveness of Vapocide™ when used as a liquid chemical sterilant in the Harvey Chemiclave Sterilizer.
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 (of Germinate) to determine the sporicidal effectiveness of Vapocide™.
Simulated Use Testing:
Simulated use testing was performed using inoculated dental Handpieces packaged in sterilization pouches processed in the Harvey Chemiclave 8000 sterilizer. The objective of this study was to determine if Bacillus stearothermophilus spores placed on the turbines inside of dental Handpieces in a medical facility would be killed when processed in the 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™ under normal use conditions (temperatures, 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™ under repeated processing of various medical and dental instruments, i.e., 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 sterilant repeated for corrosion, pitting, razing, and cracking using the scanning electron microscope and steriomicroscopic equipment.
Biological Indicator Evaluation:
The purpose of this study was to confirm that the biological indicators currently marketed were effective for use of Vapocide™ liquid chemical sterilant solution.
Residue Testing:
The objective this testing was to determine if formaldebyde residues remained on medical and dental instruments processed with Vapocide™ liquid chemical sterilant solution.
Packaging Evaluation for Sterilant Penetration:
The objective of this testing was to determine the penetration ability of unsaturated chemical vapors produced from Vapocide™ the success of the case of the case through and into typical sterilization packaging during the Harvey Chemiclave process.
Toxicity Testing:
Toxicity testing was performed on the Vapocide™ liquid chemical sterilant solution.
Skin Irritation:
This study was performed to determine if exposure to Vapocide™ produces skin irritation. This testing was performed by Gibraltar Laboratories using Vapocide™ and albino rabbits according to 40 CFR 158.135 and 158.70, Paragraph C, Pesticide Assessment Guidelines Subdivision F: Hazard Evaluation Human and Domestic Annials, Series 81-5. The results of this testing showed that the Vapocide™ sterilant is not a primary dermal irritant.
Ocular Irritation:
This study was performed to determine the ocular irritation potential of Vapocide™ following instillation in the eyes. This testing was performed by Gibraltar Laboratories according to 40 CFR 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™ as 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:
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.
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.
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
§ 880.6885 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.
0
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 --
1
4. 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.
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.
4
2
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
3
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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ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
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)
4
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
5
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.
6
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
7
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)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)