(86 days)
No
The device description and performance studies focus on the biocompatibility and lubrication properties of a water-based lubricant, with no mention of AI or ML.
No.
The device is a lubricant intended to facilitate the entry of diagnostic or therapeutic devices, but it is not itself a therapeutic device. Its purpose is to aid other devices, not to provide therapy directly.
No
The device is a lubricant intended to facilitate the entry of other devices, not to diagnose a condition itself.
No
The device description clearly states it is a "water-based lubricant," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "lubricate body orifices to facilitate entry of diagnostic or therapeutic devices." This describes a physical action performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is described as a "water-based lubricant." This is a substance applied externally or internally to reduce friction, not a reagent or instrument used to analyze a biological sample.
- 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 substances (analytes)
- Providing diagnostic information based on the analysis of a sample
The device's function is purely mechanical – to reduce friction during the insertion of other medical devices. This falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices.
Product codes
KMJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body orifices
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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6375 Patient lubricant.
(a)
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.(b)
Classification. Class I (general controls). Except when the device is a vaginal patient lubricant or an oral lubricant, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Section 5-510(k) Summary
General Information
| Owner's Name: | Spirus Medical, Inc. | APR - 3 2008 |
|---|---|---|
| Address: | 1063 Turnpike Street | |
| Stoughton, MA 02072 | ||
| Telephone Number: | (781) 297-5042 | |
| Fax Number: | (781) 297-5059 | |
| 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.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
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.
2
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
3
Image /page/3/Picture/0 description: The image shows a handwritten string of characters. The string starts with the letter 'K', followed by '080042'. The characters are written in a simple, slightly messy style, giving the impression of quick handwriting.
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)
ans and and and the commender of the commended to the commended to the commended to the commended to the world the world to the world to the world be
(Division Sign-Off) (Division of Anesthesiology, General Hospital nfection Control, Dental Devices
10(k) Number: ________________________________________________________________________________________________________________________________________________________________