ENDO-SPOR PLUS / HYPROCIDE

K972708 · Cottrell, Ltd. · MED · Sep 13, 1999 · General Hospital

Device Facts

• Record ID: K972708
• Device Name: ENDO-SPOR PLUS / HYPROCIDE
• Applicant: Cottrell, Ltd.
• Product Code: MED · General Hospital
• Decision Date: Sep 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6885
• Device Class: Class 2

Indications for Use

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

Device Story

Endo-Spor Plus™/Hyprocide™ is a liquid chemical germicide containing 7.35% hydrogen peroxide and 0.23% peracetic acid. It is used in clinical settings for high-level disinfection and sterilization of heat-labile medical devices, specifically flexible fiberoptic endoscopes. The germicide inactivates cellular metabolic enzymes and transport mechanisms of microorganisms. It is applied via immersion; high-level disinfection requires a 15-minute contact time at 20°C. The solution is reusable for up to 14 days. Healthcare providers use the germicide to process instruments between patient procedures, reducing the risk of cross-contamination. The device benefits patients by ensuring endoscopes are free of pathogens, including M. bovis and C. sporogenes, without damaging heat-sensitive instrument components. Due to potential irreversible ocular irritation, personnel must use protective equipment for face, eyes, and hands.

Clinical Evidence

Clinical testing performed on 15 flexible fiberoptic 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 tested endoscopes. Supporting bench testing included AOAC sporicidal, tuberculocidal, bactericidal, virucidal, and fungicidal tests using stressed solutions (46-day reuse). Simulated use testing on endoscope channels demonstrated 6-log reduction of M. bovis (15 min) and C. sporogenes (180 min). Material compatibility testing involved 1500 simulated cleaning cycles with no significant corrosion or damage.

Technological Characteristics

Active ingredients: 7.35% hydrogen peroxide, 0.23% peracetic acid. Mechanism: inactivation of cellular metabolic enzymes and transport mechanisms. Form factor: liquid chemical solution. Compatibility: tested on metallic, plastic, and rubber endoscope components. No software or electronic components.

Indications for Use

Indicated for chemical disinfection and sterilization of flexible lensed endoscopy instruments, inhalation therapy equipment, and heat-labile medical/dental instruments.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Omnicide and Procide 14 N.S. sterilants/disinfectants (K932922)
• Cidex liquid chemical sterilants/disinfectants (K923744, K924334, K924434)
• STERIS 20 (K875250)

Submission Summary (Full Text)

{0}------------------------------------------------

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 [phone]

#### 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

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.

{1}------------------------------------------------

#### 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 subtilis<br>Clostridium sporogenes | Meets sporicidal efficacy<br>requirements |
| Simulated Use Test | Mycobacterium bovis<br>Clostridium sporogenes | Meets efficacy requirements |
| Quantitative<br>Tuberculocidal Test | Mycobacterium bovis | Stressed solution is<br>tuberculocidal |
| AOAC Use Dilution<br>Test | Pseudomonas aeruginosa<br>Staphylococcus aureus<br>Salmonella choleraesius | Stressed solution is bactericidal |
| EPA Virucidal Testing<br>(DIS/TSS-7, November<br>1981) | Herpes Simplex I<br>Poliovirus Type II<br>Human Immunodeficiency Virus Type I | Stressed solution is virucidal |
| AOAC Fungicidal Test | Trichophyton mentagrophytes | Stressed solution is fungicidal |

Table A Microbicidal Efficacy Testing

{2}------------------------------------------------

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™

{3}------------------------------------------------

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.

{4}------------------------------------------------

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

{5}------------------------------------------------

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

{6}------------------------------------------------

Page_of

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Endo-Spor Plus "/Byprocide™

Indications For Use:

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.

(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)