(86 days)
Intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices.
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.
The provided text describes a 510(k) premarket notification for the Spirus Medical Lubricant, a Class I patient lubricant. The information given is limited and focuses on the regulatory aspects rather than detailed study results to prove acceptance criteria.
Based on the provided text, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: | |
| Biocompatibility | "Biocompatibility testing was conducted on the finished device in accordance with ISO 10993." (Implied acceptance met due to "predetermined acceptance criteria") |
| Effectiveness: | |
| Substantial Equivalence to Predicate Device | "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." (Implied acceptance met due to "predetermined acceptance criteria") |
| Lubrication of body orifices to facilitate entry of diagnostic or therapeutic devices | The device is "intended for lubrication of a body orifice to facilitate entry of a diagnostic or therapeutic device." The conclusion states it "meets all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness." This implies the lubricant successfully performs its intended function. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a sample size for any test set or the data provenance. It mentions "biocompatibility testing" and "comparison of the chemical formula" but provides no details on the studies themselves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available in the provided document. The submission relies on chemical comparison and biocompatibility testing, not on expert-driven "ground truth" establishment in a diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessment, which is not described here.
5. 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
A multi-reader, multi-case (MRMC) comparative effectiveness study is not mentioned and is not applicable to a patient lubricant. This type of study is typically used for diagnostic devices involving human interpretation (e.g., radiologists analyzing medical images with and without AI assistance).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to a medical lubricant. A lubricant does not involve an algorithm or "standalone" performance in the way a diagnostic AI would.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For biocompatibility testing, the "ground truth" would be established by the biological response of cells/tissues to the lubricant, as defined by the ISO 10993 standards. For substantial equivalence, the ground truth is the chemical formula of the predicate devices. There is no mention of expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This information is not available in the provided document. The device is a lubricant, not a machine learning model, so typical "training set" concepts do not apply.
9. How the ground truth for the training set was established
This information is not available and not applicable.
Summary of Device Acceptance:
The Spirus Medical Lubricant "meets all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness." The study that proves this is based on:
- Chemical Comparison: Substantial equivalence was established by comparing the chemical formula of the proposed device to that of predicate devices (K-Y Lubricating Jelly and Probe Personal Lubricant). This comparison is the primary method for demonstrating effectiveness in terms of physical properties expected of a lubricant.
- Biocompatibility Testing: The device underwent testing in accordance with ISO 10993 standards to ensure safety for patient contact.
The document explicitly states: "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 equivalent to the predicate devices." This concise statement confirms that the studies performed (chemical comparison and biocompatibility) were deemed sufficient to meet the regulatory requirements for a Class I patient lubricant seeking 510(k) clearance. Specific data, sample sizes, and detailed methodology of these tests are not provided in this summary.
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Section 5-510(k) Summary
General Information
| Owner's Name: | Spirus Medical, Inc. | APR - 3 2008 |
|---|---|---|
| Address: | 1063 Turnpike StreetStoughton, 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.
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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 (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
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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: ________________________________________________________________________________________________________________________________________________________________
§ 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.