STERI-LUB LUBRICATION GEL
Device Facts
| Record ID | K083189 |
|---|---|
| Device Name | STERI-LUB LUBRICATION GEL |
| Applicant | Avail Medical Products, Inc. |
| Product Code | KMJ · General Hospital |
| Decision Date | Nov 21, 2008 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 880.6375 |
| Device Class | Class 1 |
Intended Use
The Steri-Lub™ Lubrication Gel is intended to be used in procedures requiring a sterile product (surgical, urological). The Lubrication Gel is intended to be used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
Device Story
Steri-Lub™ Lubrication Gel is a sterile, single-patient-use, disposable lubricant provided in a pre-filled syringe. It is used in clinical settings, specifically for surgical and urological procedures. The gel is applied to a body orifice to reduce friction, thereby facilitating the insertion of diagnostic or therapeutic instruments. The device is intended for use by healthcare professionals. It provides a sterile interface to assist in clinical procedures, potentially improving patient comfort and reducing trauma during device insertion.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Sterile, single-patient-use, disposable pre-filled syringe containing lubrication gel. Materials of construction are similar to the predicate device.
Indications for Use
Indicated for use in surgical and urological procedures requiring a sterile lubricant to facilitate the entry of diagnostic or therapeutic devices into a body orifice.
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
- Steri-Lub™ Lubrication Gel (K944060)
Related Devices
- K103718 — DYNACOR LUBRICATION GEL · Medline Industries, Inc. · May 10, 2011
- K974768 — PDI STERILE LUBRICATING JELLY · Nice-Pak Products, Inc. · Jan 16, 1998
- K081990 — LUBRICANO STERILE GEL · Farco Pharma GmbH · Dec 5, 2008
- K041060 — E-Z LUBRICATING JELLY · Chester Labs, Inc. · May 7, 2004
- K113689 — DUKAL LUBRICATING JELLY · Dukal Corporation · May 4, 2012
Submission Summary (Full Text)
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## AVAIL MEDICAL PRODUCTS, INC., Device Modification - Special 510(k), Steri-LubTM Lubrication Gel
## SECTION 5: 510(k) Summary
K\$\phi\$83189
NOV 21 2008
| Submitter: | Avail Medical Products, Inc.<br>1900 Carnegie Avenue<br>Santa Ana, CA 92705 |
|-------------------|-----------------------------------------------------------------------------|
| Contact: | Hanumantha Hari<br>949-263-5060 ext. 267 |
| Name of Device: | Steri-Lub™ Lubrication Gel |
| Predicate Device: | Steri-Lub™ Lubrication Gel, K944060 |
Description of the New Device: The Steri-LubTM Lubrication Gel is a sterile, single patient use, disposable instrument that is substantially equivalent to the predicate device and other pre-filled syringes. All Steri-Lubrication Gel syringes are designed for lubrication of a body orifice to facilitate entry of a diagnostic or therapeutic device only and are intended for single patient use.
INTENDED USE OF THE NEW DEVICE: The Steri-Lub™ Lubrication Gel is intended to be used in procedures requiring a sterile product (surgical, urological). The Lubrication Gel is intended to be used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
Comparison of the Technological Features of the New [Modified] Device and Predicate Devices: The modified device and the lawfully marketed predicate device contain similar materials of construction.
Signed,
igned,
Hanumantha Hari Vice President Quality and Regulatory Affairs Avail Medical Products, Inc.
CONFIDENTIAL
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patricia Anne Goeree Regulatory Affairs Specialist Avail Medical Products, Incorporated 1900 Carnegie Avenue Santa Ana, California 92705
NOV 21 2008
Re: K083189
Trade/Device Name: Stori-Lub™ Lubrication Gel Regulation Number: 21 CFR 880.6375 Regulation Name: Patient Lubricant Regulatory Class: I Product Codc: KMJ Dated: October 28, 2008 Received: October 30, 2008
Dear Ms. Gocree:
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. Goeree
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu S. Lin, Ph.D.
Chiu S. Lin, Ph. D Division 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
510(k) Number (if known):
Device Name:___Steri-Lub TM Lubricating Gel
Indications For Use:
The Steri-Lub Lubricating Gel is intended to be used in procedures requiring a sterile product (surgical and urological). The Lubrication Gel is intended to be used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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 Infection Control, Dental Devices
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K483189 510(k) Number:
