(146 days)
Not Found
No
The device description and performance studies focus on the physical and biological properties of a lubricant, with no mention of AI or ML technology.
No.
The device is a lubricant intended to facilitate the entry of diagnostic and therapeutic devices, not a therapeutic device itself.
No
The device is a patient lubricant intended to facilitate the entry of diagnostic and therapeutic devices, not to diagnose.
No
The device description clearly describes a physical product (patient lubricant in a tube) and its physical properties and packaging. There is no mention of software as a component of the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "lubricate orifices to facilitate the entry of diagnostic and therapeutic devices." This describes a physical aid for a medical procedure, not a device that performs a diagnostic test on a sample taken from the body.
- Device Description: The description focuses on the physical properties of the lubricant (water-based, clear, odorless, etc.) and its packaging and sterilization. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document 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) in a sample
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
- Performance Studies: The performance studies described are related to biocompatibility and safety for topical use, not the analytical performance of a diagnostic test.
In summary, the device is a medical lubricant used to facilitate procedures, not a device that performs a diagnostic test on a sample. Therefore, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KMJ
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.
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)
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. Therefore, the test article is not 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
E-Z Lubricating Jelly (Sterile), manufactured by Chester Labs Inc. (K041060), PDI Lubricating Jelly (Sterile), manufactured by Nice-Pak Products, Inc. (K974768)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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.
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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
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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
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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.
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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).