(146 days)
Patient lubricant intended for medical purposes to lubricate orifices to facilitate the entry of diagnostic and therapeutic devices. The device is intended for use on order of a physician.
Sheffield Pharmaceuticals Sterile LubriGel patient lubricant is a waterbased, clear, colorless, odorless, non-sticky, non-greasy, non-staining, nonirritating patient lubricant. It is a water soluble, high viscosity gel-like liquid for use as patient lubricant when a sterile field is required. Each tube is terminally sterilized. The product is sterile unless package is opened or damaged with label directions to discard after use.
The product is packaged in a convenient 4.0 oz laminate tube with a flip top cap and peel seal.
This product is not a contraceptive and does not contain a spermicide.
This document is a 510(k) Summary for Sheffield Pharmaceuticals Sterile LubriGel, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria of the type often found for AI/ML medical devices. The information provided is primarily related to product identification, regulatory classification, intended use, device description, and technological characteristics, as well as biocompatibility testing to show safety.
Therefore, many of the specific questions about acceptance criteria for device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance are not directly applicable or available in this type of submission document. This submission is for a Class I patient lubricant, and the "performance" is largely demonstrated through comparison to existing products and safety testing.
However, I can extract the relevant information that is present in the document.
1. A table of acceptance criteria and the reported device performance
Since this is a submission for a patient lubricant, the "performance" is tied to its physical characteristics and safety. The acceptance criteria aren't explicitly stated in a quantitative table with reported values against thresholds, but rather as qualitative statements of safety and equivalence.
| Characteristic / Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Physical Characteristics | - Water-based, clear, colorless, odorless, non-sticky, non-greasy, non-staining, non-irritating, water soluble, high viscosity gel-like liquid | "Sheffield Pharmaceuticals Sterile LubriGel patient lubricant is a waterbased, clear, colorless, odorless, non-sticky, non-greasy, non-staining, non-irritating patient lubricant. It is a water soluble, high viscosity gel-like liquid for use as patient lubricant when a sterile field is required." |
| Sterility | Sterile (unless package is opened or damaged) | "Each tube is terminally sterilized. The product is sterile unless package is opened or damaged with label directions to discard after use." |
| Biocompatibility - Dermal Sensitization | Non-sensitizer | "In Delayed Contact Dermal Sensitization Test (Buehler Method) the product was considered a non-sensitizer." |
| Biocompatibility - In Vitro Cytotoxicity | Meet requirements for the test | "In Vitro Cytotoxicity L929 Agar Overlay Test the product meet the requirements for the test." |
| Biocompatibility - Primary Dermal Irritation | Not a dermal irritant | "Primary Dermal Irritation in Rabbits determined that the product is not a dermal . irritant." |
| Biocompatibility - Single Dose Oral Toxicity | Not toxic (e.g., LD50 > 5000 mg/kg) | "Single Dose Oral Toxicity in Rats showed the oral LD50 of Sheffield's Sterile . LubriGel as greater that 5000 mg/kg of body weight. Therefore, the test article is not toxic." |
| "Performance" against Predicate Devices (overall) | Substantially equivalent in safety and effectiveness | "Sheffield Pharmaceuticals Sterile LubriGel has been shown, in laboratory test, to be substantially equivalent to the current marketed E-Z Lubricating Jelly and PDI (Sterile) Lubricating Jelly." and "Laboratory testing conducted on Sheffield Pharmaceutical Sterile LubriGel has provided scientific evidence that this product is safe for its intended use and substantially equivalent to the predicated E-Z Lubricating Jelly (Sterile), and PDI Lubricating Jelly (Sterile)." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in terms of units of lubricant or patient cases. For biocompatibility tests, animal models were used (Buehler Method, L929 Agar Overlay, Rabbits for dermal irritation, Rats for oral toxicity). The number of animals/samples used in these specific tests is not provided.
- Data Provenance: "Biocompatibility Studies on Sheffield's Sterile LubriGel was conducted by outside laboratories, in compliance with Good Laboratory Practices (GLPs)." The country of origin and whether the studies were retrospective or prospective are not specified, though GLP compliance implies a prospective, controlled study design for safety testing.
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)
Not applicable. This device is a Class I lubricant, and its "ground truth" for performance is based on physical/chemical properties and biological safety tests (biocompatibility), not expert interpretation of diagnostic images or clinical outcomes in the same way an AI/ML device would be assessed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See point 3.
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
Not applicable. This is a hardware device (lubricant), not an AI/ML diagnostic or therapeutic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device (lubricant), not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's safety and effectiveness is established through:
- Physical and Chemical Properties: Demonstrated internally.
- Biocompatibility Testing: Conducted by outside laboratories following GLP standards, using established laboratory protocols and animal models to assess sensitization, cytotoxicity, dermal irritation, and oral toxicity. The results of these tests (e.g., "non-sensitizer," "meet requirements," "not a dermal irritant," "LD50 > 5000 mg/kg") serve as the evidence or "ground truth" for safety.
- Comparison to Predicate Devices: The overall claim of substantial equivalence is based on similar technological characteristics and the demonstration of equivalent safety profile through testing, aligning with data on the predicate devices (E-Z Lubricating Jelly and PDI Lubricating Jelly).
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 15, 2017
Sheffield Pharmaceuticals Kathleen Hacku Quality Assurance Manager 170 Broad Street New London, CT 06320
Re: K073684
Trade/Device Name: Sheffield Brand Sterile LubriGel Regulation Number: 21 CFR 880.6375 Regulation Name: Patient Lubricant Regulatory Class: I Product Code: KMJ Dated: April 8, 2008 Received: April 14, 2008
Dear Kathleen Hacku:
This letter corrects our substantially equivalent letter of May 22, 2008.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
{1}------------------------------------------------
Page 2 - Kathleen Hacku
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Tina
Kiang -S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
510(k) INDICATIONS FOR USE FORM (Replica of FDA Form)
510 (k) Number (if known):
Device Name: Sheffield Pharmaceuticals (Sterile) LubriGel
Indications for Use:
Patient lubricant intended for medical purposes to lubricate orifices to facilitate the entry of diagnostic and therapeutic devices. The device is intended for use on order of a physician.
Non-Prescription Over-the-counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON AN OTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (per 21 CFR 801.109) | |
| OR Over-the-Counter-Use | ✓ |
(Division Sign-Off)
[Signature]
Division of Reproductive, Abdominal, and Radiological Device
510(k) Number K07136
{3}------------------------------------------------
MAY 2 2 2008
Image /page/3/Picture/1 description: The image shows the logo for Sheffield Pharmaceuticals. The logo consists of a square graphic on the left, followed by the word "SHEFFIELD" in a bold, sans-serif font. Below "SHEFFIELD" is the word "PHARMACEUTICALS", also in a bold, sans-serif font, but slightly smaller than "SHEFFIELD". The overall design is clean and professional.
510(k) Summary
Faria Limited, LLC dba Sheffield Pharmaceuticals Applicant: 170 Broad Street New London, Ct. 06320 USA
| Signature of Applicant: | |
|---|---|
| THF | |
| Thomas H. Faria - President | Date |
| 5/21/08 | |
| Phone: | (860) 442-4451 |
| Fax: | (860) 442-0356 |
| Contact: | Kathleen Hacku |
| Quality Assurance Manager | |
| Date: | December 15, 2007 |
| Manufacturing Site: | Faria Limited, LLC dba Sheffield Pharmaceuticals |
| 170 Broad Street | |
| New London, Ct. 06320 USA | |
| Registration Number: | 1210513 |
| Device Class: | Class I (reserved) |
| Trade Name: | Sheffield Pharmaceuticals LubriGel |
| Common Name: | Personal Lubricant |
| Classification Name: | Patient Lubricant |
| C.F.R. section: | 21 CFR section 880.6375 |
| Classification Panel: | Obstetrical/Gynecological |
| New Device's Name: | Sheffield Pharmaceuticals Sterile LubriGel |
| Predicated Device(s): | E-Z Lubricating Jelly (Sterile), manufactured by Chester Labs Inc. (K041060) |
| PDI Lubricating Jelly (Sterile), manufactured by Nice-Pak Products, Inc. (K974768) |
170 BROAD STREET, NEW LONDON, CT 06320 USA . TEL 800.222.1087 . FAX 860.442.0356 GENERAL@SHEFFIELD-PHARMACEUTICALS.COM . WWW.SHEFFIELD-PHARMA.COM
1 of 3
{4}------------------------------------------------
Information supporting claims of substantial equivalence, as defined under the Federal Food Drug and Cosmetic Act, with respect to safety and effectiveness is summarized below. For the convenience of the reviewer, this summary is formatted in accordance with the Agency's final rule, "510(k) Summaries and 510(k) Statements" (21 CFR 807).
Intended Use:
Sheffield Pharmaceutical Sterile LubriGel is a medical device intended for medical purposes to lubricate body orifices to facilitate the entry of diagnostic and therapeutic devices.
Device Description:
Sheffield Pharmaceuticals Sterile LubriGel patient lubricant is a waterbased, clear, colorless, odorless, non-sticky, non-greasy, non-staining, nonirritating patient lubricant. It is a water soluble, high viscosity gel-like liquid for use as patient lubricant when a sterile field is required. Each tube is terminally sterilized. The product is sterile unless package is opened or damaged with label directions to discard after use.
The product is packaged in a convenient 4.0 oz laminate tube with a flip top cap and peel seal.
This product is not a contraceptive and does not contain a spermicide.
Regulatory Status:
As per 21CFR, 880.6375, Patient Lubricant is defined as a Class I medical device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. Patient lubricants are not exempt from 510(k) clearance.
Technological Characteristics:
Sheffield Pharmaceuticals Sterile LubriGel formula is proprietary. The product has no exceptional technological characteristics and consists mainly of safe water soluble GRAS status ingredients, similar to PDI (Sterile) Lubricating Jelly, and E-Z Lubricating Jelly currently on the market. Sheffield's (Sterile) LubriGel contains: Water. Natural Glyccrin, Peg 6. Carbopol, Peg 32, Sodium Hydroxide, Methylparaben and Propylbaraben.
Summary of Technological Characteristics:
Sheffield Pharmaceuticals Sterile LubriGel has been shown, in lahoratory test, to be substantially equivalent to the current marketed F-Z Lubricating Jelly and PDI (Sterile) Lubricating Jelly.
{5}------------------------------------------------
Biocompatibility Studies
Biocompatibility Studies on Sheffield's Sterile LubriGcl was conducted by outside laboratories, in compliance with Good Laboratory Practices (GLPs) demonstrated:
- In Delayed Contact Dermal Sensitization Test (Buehler Method) the product was . considered a non-sensitizer.
- In Vitro Cytotoxicity L929 Agar Overlay Test the product meet the requirements ◆ for the test.
- Primary Dermal Irritation in Rabbits determined that the product is not a dermal . irritant.
- Single Dose Oral Toxicity in Rats showed the oral LD50 of Sheffield's Sterile . LubriGel as greater that 5000 mg/kg of body weight. Thereforc, the test article is nol toxic.
Laboratory testing conducted on Sheffield Pharmaceutical Sterile LubriGel has provided scientific evidence that this product is safe for its intended use and substantially equivalent to the predicated E-Z Lubricating Jelly (Sterile), and PDI Lubricating Jelly (Sterile).
§ 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.