Endo-Spor Plus™ liquid chemical germicide is intended for the disinfection and sterilization of endoscopic instruments and other heat labile medical and dental instruments.

Endo-Spor Plus™Hyprocide™is a chemical disinfecting and sterilization solution for use on flexible lensed endoscopy instruments, inhalation therapy equipment and instruments and materials that cannot be heat sterilized.

Device Description

The liquid chemical germicide Endo-Spor Plus™ contains the active ingredients hydrogen peroxide and peracetic acid. The germicide can be used as a high level disinfectant with a contact time of 15 minutes at 20℃ under reuse conditions of up to 14 days.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Endo-Spor Plus™/Hyprocide™ Liquid Chemical Germicide, based on the provided text:

Acceptance Criteria and Device Performance

Note: The document does not explicitly state "acceptance criteria" as a separate, quantitative table. Instead, it presents performance results as meeting specific efficacy requirements for various tests. The table below synthesizes this information.

Acceptance Criteria (Implied)	Reported Device Performance
Microbicidal Efficacy:
- Sporicidal efficacy (B. subtilis, C. sporogenes)	Meets sporicidal efficacy requirements
- Tuberculocidal efficacy ($M.$ bovis)	Stressed solution is tuberculocidal
- Bactericidal efficacy ($P.$ aeruginosa, $S.$ aureus, $S.$ choleraesius)	Stressed solution is bactericidal
- Virucidal efficacy (Herpes Simplex I, Poliovirus Type II, HIV Type I)	Stressed solution is virucidal
- Fungicidal efficacy ($T.$ mentagrophytes)	Stressed solution is fungicidal
Minimal log reduction for M. bovis (simulated use)	6-log reduction on interior and exterior surfaces
Minimal log reduction for C. sporogenes (simulated use)	6-log reduction
No surviving microorganisms after clinical use	No surviving microorganisms on any tested endoscope
Residue:
No detectable residual hydrogen peroxide/peracetic acid	No detectable hydrogen peroxide or peracetic acid
Toxicology:
Non-irritating (primary dermal)	Non-irritating
Dermal LD50 >2 g/kg body weight (acute dermal)	Dermal LD50 >2 g/kg body weight
Non-sensitizing (skin sensitization)	Non-sensitizing
Non-mutagenic (Ames test)	Non-mutagenic
Oral LD50 >5 g/kg body weight (acute oral)	Oral LD50 >5 g/kg body weight
Minimal ocular irritation (no specific threshold stated, but adverse outcome noted)	Irreversible Irritation (2 of 6 rabbits)
Material Compatibility:
No corrosion or visible damage after simulated cleaning cycles	No corrosion or other visible damage to endoscope components
Adhesion of adhesives maintained (at specified temperatures)	Reduced adhesion at elevated temperatures (attributed to temp, not solution)

Study Details

Sample size used for the test set and the data provenance:
- Simulated Use Test: Not explicitly stated for each organism.
  - For M. bovis and C. sporogenes contaminated endoscopes, the results refer to 6-log reductions, implying a sufficient number of tests to establish this.
- Clinical Testing: 15 flexible fiberoptic endoscopic retrograde cholangiopancreatography (ERCP) endoscopes.
- Residue Testing: A "series of Olympus endoscopes." (Specific number not given).
- Toxicology Testing:
  - Primary Dermal Irritation: Not specified, but standard tests involve multiple animals (e.g., rabbits).
  - Acute Dermal Toxicity: Not specified.
  - Ocular Irritation: 6 rabbits.
  - Acute Oral Toxicity: Not specified.
  - Skin Sensitization: Not specified.
  - Mutagenicity (Ames test): Not specified, typically uses bacterial strains grown in cultures.
- Material Compatibility: "a variety of metallic, plastic and rubber endoscope components" (specific number of components/tests not given) and "a number of different adhesives."
- Data Provenance: The document does not explicitly state the country of origin. Given the submission to the FDA, it's likely part of US regulatory submissions, but the actual lab locations are not provided. The studies appear to be prospective experimental studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of device (liquid chemical germicide) relies on laboratory efficacy testing against standardized microorganisms and physical/chemical properties rather than human expert interpretation of images or clinical findings. Therefore, neither a number of experts nor their qualifications for establishing ground truth in the traditional sense (e.g., radiologists reading images) is applicable or provided. The "ground truth" here is the direct, measurable outcome of the microbiological, chemical, and biological tests.
Adjudication method for the test set:
- Not applicable as the study involves objective laboratory measurements and efficacy validation, not subjective expert assessment requiring adjudication.
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:
- Not applicable. This is not an AI/imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/imaging device. Its "standalone" performance is its microbicidal efficacy and material compatibility as tested in the lab.
The type of ground truth used:
- Microbiological Efficacy: Laboratory culture results and log reduction measurements.
- Residue Testing: Chemical analytical measurements (detectable levels of hydrogen peroxide/peracetic acid).
- Toxicology: In vivo animal model observations for irritation, toxicity, and sensitization, and in vitro Ames test for mutagenicity.
- Material Compatibility: Visual inspection for damage, weight change, flexibility, adhesion, and corrosion.
The sample size for the training set:
- Not applicable. This is not a machine learning device. The "training" for a chemical germicide comes from chemical formulation and established microbiological testing protocols.
How the ground truth for the training set was established:
- Not applicable. (See #7). The "ground truth" for the effectiveness of the chemical components is based on established scientific principles of germicidal action and empirical data from chemical and microbiological research, not on a "training set" in the machine learning sense. The performance data presented are for the final product evaluation.

Summary

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K972708

510(k) Summary Endo-Spor Plus™/Hyprocide™ Liquid Chemical Germicide Date Prepared: September 1, 1999

SUBMITTER NAME AND ADDRESS 1.

John R. Scoville, Jr. Cottrell, Ltd. 7399 South Tucson Way Englewood, CO 80112 (303) 799-9401

2. DEVICE NAME

Proprietary Name: Common/Usual Name: Classification Name:

Endo-Spor Plus™/Hyprocide™ Liquid Chemical Germicide Liquid Chemical Germicide

PREDICATE DEVICES 3.

Omnicide and Procide 14 N.S. sterilants/disinfectants (K932922), manufactured by Cottrell, Ltd.; Cidex liquid chemical sterilants/disinfectants (K923744, K924334, K924434), manufactured by Johnson & Johnson; STERIS 20 (K875250), manufactured by STERIS Corporation.

INTENDED USE 4.

Endo-Spor Plus™ liquid chemical germicide is intended for the disinfection and sterilization of endoscopic instruments and other heat labile medical and dental instruments.

ડ. DEVICE DESCRIPTION

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TECHNOLOGICAL CHARACTERISTICS 6.

Endo-Spor Plus™ liquid chemical germicide contains 7.35% hydrogen peroxide and 0.23% peracetic acid. While the active ingredients are different than that of the predicate devices, which contain glutaraldehyde (Cidex, Omnicide) or peracetic acid (STERIS 20), the microbicidal efficacy of all these liquid chemical germicides is attributed to the inactivation of cellular metabolic enzymes and transport mechanisms.

Like the predicate devices, the microbicidal efficacy of Endo-Spor Plus™ increases with contact time. Endo-Spor Plus™ can be used for high level disinfection with a contact time of 15 minutes at 20℃. The contact times required for high level disinfection and sterilization of the Endo-Spor Plus™ are less than those of the predicate devices due to the synergistic effect of the active ingredients.

PERFORMANCE TESTING 7.

All performance testing was conducted in the presence of 5% calf serum or with Endo-Spor Plus™ solution which was stressed for 46 days using EPA Use-Reuse Stressing Protocol using solutions at or close to the expiration date and at the end of the reuse period. Tuberculocidal efficacy of the germicide solution was evaluated using a number of test methods. The test methods and a summary of results are presented in Table A.

Test Method	Test Organisms(s)	Results
AOAC Sporicidal Test	Bacillus subtilisClostridium sporogenes	Meets sporicidal efficacyrequirements
Simulated Use Test	Mycobacterium bovisClostridium sporogenes	Meets efficacy requirements
QuantitativeTuberculocidal Test	Mycobacterium bovis	Stressed solution istuberculocidal
AOAC Use DilutionTest	Pseudomonas aeruginosaStaphylococcus aureusSalmonella choleraesius	Stressed solution is bactericidal
EPA Virucidal Testing(DIS/TSS-7, November1981)	Herpes Simplex IPoliovirus Type IIHuman Immunodeficiency Virus Type I	Stressed solution is virucidal
AOAC Fungicidal Test	Trichophyton mentagrophytes	Stressed solution is fungicidal

Table A Microbicidal Efficacy Testing

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Simulated use testing was conducted using the insertion tubes and air water channels of flexible fiberoptic endoscopes which were contaminated in the insertion tubes with >100 cfuml of M. bovis or C. sporogenes. The results showed a 6-log reduction in M. bovis on both interior and exterior surfaces after a 15-minute contact time at 20°C and a 6-log reduction of C. sporogenes after 180 minutes contact at 20℃.

Clinical testing was conducted on 15 flexible fiberoptic endoscopic retrograde cholangiopancreatography (ERCP) endoscopes with elevator channels. Endoscopes were immersed in Endo-Spor Plus™ for 5 minutes at 20°C. Results showed no surviving microorganisms on any of the endoscopes tested.

The results of the microbicidal efficacy, simulated use and clinical testing demonstrate that the liquid chemical germicide Endo-Spor Plus™ is safe and effective for the disinfection and sterilization of endoscopic instruments at the temperatures and contact times specified.

Residue testing was performed on a series of Olympus endoscopes to quantitate any residual hydrogen peroxide and/or peracetic acid remaining after residue reduction had been performed. The rinse water and the exposed surfaces of the endoscopes were tested. The results showed no detectable hydrogen peroxide or peracetic acid recovered in the rinse water or on the endoscope surfaces.

Testing was performed to determine the potential toxicological affects of exposure to Endo-Spor Plus™ liquid chemical germicide. The individual tests performed and the results are summarized in Table B.

Toxicology Test	Results
Primary Dermal Irritation	Non-irritating
Acute Dermal Toxicity	Dermal $LD_{50}$ >2 g/kg body weight
Ocular Irritation	Irreversible Irritation
Acute Oral Toxicity	Oral $LD_{50}$ >5 g/kg body weight
Skin sensitization	Non-sensitizing
Mutagenicity (Ames test)	Non-mutagenic

Table B. Toxicological Evaluation of Endo-Spor Plus™

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The results of the toxicity testing showed Endo-Spor Plus™ to be non-toxic and not a dermal irritant. However, there was evidence of irreversible ocular irritation 2 of the 6 rabbits tested. A warning has been included in the labeling recommending use of personnel protection equipment to protect face, eyes, and hands.

The material compatibility of the Endo-Spor Plus™ liquid chemicals germicide was evaluated by subjecting a variety of metallic, plastic and rubber endoscope components to 1500 simulated cleaning cycles, which is equivalent to 2000, 15 minute high level disinfection cycles or 166, 180 minute sterilization cycles at 20℃. The samples were inspected for weight change, visible evidence of damage or any other change in appearance. The results were compared with those obtained from an identical set of endoscope components where tap water was substituted for Endo-Spor Plus™ in the solution used for the 1500 simulated cleaning cycles. The data indicates that the Endo-Spor Plus™ does not produce any corrosion or other visible damage in endoscope components. Color changes were noted on anodized aluminum parts in both the Endo-Spor Plus™ and water tests.

A separate evaluation was performed to determine the effects of Endo-Spor Plus™ on a number of different adhesives used in the manufacture of flexible endoscopes. Adhesives were applied to aluminum and polypropylene and their appearance, flexibility and adhesion tested after prolonged immersion in Endo-Spor Plus™ or tap water at temperatures of 20-63°C. The results show reduced adhesion at elevated temperatures in samples from both the Endo-Spor Plus™ and tap water tests, suggesting that the effect was due to elevated temperature rather than the Endo-Spor Plus™ solution itself.

CONCLUSION

Endo-Spor Plus™ is substantially equivalent to the listed predicate products when Endo-Spor Plus™ is used in accordance with its label instructions.

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Image /page/4/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol resembling a bird in flight, composed of several curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 3 1999

Mr. Jack Scoville Vice President Cottrell. Limited 7399 South Tucson Way 80112 Englewood, Colorado

Re: K972708 Trade Name: Endo-Spor Plus/Hyprocide Requlatory Class: Unclassified Product Code: MED Dated: April 15, 1999 Received: April 15, 1999

Dear Mr. Scoville:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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, qood manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Scoville

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 leqally 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) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under 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/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Page_of

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Endo-Spor Plus "/Byprocide™

Indications For Use:

(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 K972708

OVER THE COUNTER
DEVICE

(Optional Format 3-10-98)

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.