SPIRUS MEDICAL SURGICAL INSTRUMENT

K080042 · Spirus Medical, Inc. · KMJ · Apr 3, 2008 · General Hospital

Device Facts

• Record ID: K080042
• Device Name: SPIRUS MEDICAL SURGICAL INSTRUMENT
• Applicant: Spirus Medical, Inc.
• Product Code: KMJ · General Hospital
• Decision Date: Apr 3, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6375
• Device Class: Class 1

Indications for Use

Intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices.

Device Story

Spirus Medical Lubricant is a water-based lubricant used to facilitate the insertion of diagnostic or therapeutic devices into body orifices. It is applied topically by healthcare providers during clinical procedures. The device functions by reducing friction between the medical instrument and the patient's tissue, thereby easing entry and potentially increasing patient comfort. It is a simple, non-electronic, chemical-based product.

Clinical Evidence

No clinical data. Safety and effectiveness were established through chemical formula comparison and biocompatibility testing conducted in accordance with ISO 10993.

Technological Characteristics

Water-based patient lubricant. Biocompatibility testing performed per ISO 10993.

Indications for Use

Indicated for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices in patients requiring such procedures.

Regulatory Classification

Identification

A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.

Predicate Devices

• K-Y Lubricating Jelly (K810310)

Reference Devices

• Probe Personal Lubricant (K952464)

Submission Summary (Full Text)

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K080042

## Section 5-510(k) Summary

### General Information

| Owner's Name: | Spirus Medical, Inc. | APR - 3 2008 |
|-------------------------|-------------------------------------------------|--------------|
| Address: | 1063 Turnpike Street<br>Stoughton, MA 02072 | |
| Telephone Number: | [phone] | |
| Fax Number: | [phone] | |
| Contact Person: | Robert Ailinger | |
| Subject Device Name: | Spirus Medical Lubricant | |
| Trade Name: | Spirus Medical Lubricant | |
| Common/Usual Name: | Patient lubricant | |
| Product Code: | KMJ | |
| FDA Regulation: | 21 CFR 880.6375 - Patient Lubricant | |
| Device Classification: | Class I | |
| Predicate Device Names: | | |
| Trade Name: | K-Y Lubricating Jelly (Johnson & Johnson, Inc.) | |
| Common/Usual Name: | Patient lubricant | |
| Product Code: | KMJ | |
| FDA Regulation: | 21 CFR 880.6375 - Patient Lubricant | |
| Device Classification: | Class I | |
| Premarket Notification: | K810310 | |

Trade Name: Common/Usual Name: Product Code: FDA Regulation: Device Classification: Premarket Notification: Probe Personal Lubricant (Davryan Laboratories, Inc.) Condom & accessories HIS 21 CFR 884.5300 - Condom Class II K952464

### Device Description

The Spirus Medical Lubricant is a water-based lubricant intended for lubrication of a body orifice to facilitate entry of a diagnostic or therapeutic device.

#### Indications for Use

For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices.

### Substantial Equivalence

Substantial Equivalence for the Spirus Medical Lubricant has been established by comparison of the chemical formula for the proposed device vs. that of the predicate devices. Biocompatibility testing was conducted on the finished device in accordance with ISO 10993.

### Conclusion

The Spirus Medical Lubricant meets all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness; the Spirus Lubricant is substantially cquivalent to the predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 3 2008

Spirus Medical, Incorporated C/O Ms. Pamela Papineau President, Regulatory Affairs Consultant Delphi Medical Device Consulting, Incorporated 5 Whitcomb Avenue Ayer, Massachusetts 01432

Re: K080042

Trade/Device Name: Spirus Medical Lubricant Regulation Number: 880.6375 Regulation Name: Patient Lubricant Regulatory Class: I Product Code: KMJ Dated: December 30, 2008 Received: January 8, 2008

Dear Ms Papineau:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally 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) that do not require approval of a premarket approval application (PMA). 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, 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 your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Papineau

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 requirements 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

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# Indications for Use Statement

510(k) Number (if known):

Spirus Medical Lubricant Device Name:

Indications for Use:

Intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices.

OR Prescription Use _ (Per 21 CFR 801 Subpart D)

.

Over-the -Counter Use X (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

10(k) Number: ________________________________________________________________________________________________________________________________________________________________