The subject device is a terminally gamma sterilized 10cc polypropylene plastic syringe filled with United Guardian lubricating jel and capped with a polypropylene plastic cap. United Guardian has a Master File Reference for its lubrication jel, Master File for Devices MAF-613 pertaining to Lubrajel RR. All components of the device are gamma irradiation stable.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device, specifically a "Sterile Lube Jelly Pre-Filled Syringe," asserting its substantial equivalence to a legally marketed predicate device. The information details non-clinical performance data rather than a clinical study involving human patients or a complex AI algorithm. Therefore, many of the requested categories related to clinical trials, AI, ground truth, and expert evaluation are not applicable to this submission.

Here's a breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

The device, the Nurse Assist Lube Jelly Pre-Filled Syringe, aims to demonstrate substantial equivalence to the predicate device, the Horizon Steri-Lub Lubrication Gel. The acceptance criteria are implicit in showing that the device's characteristics and performance are comparable to the predicate.

Acceptance Criteria Category	Reported Device Performance (Nurse Assist Lube Jelly Pre-Filled Syringe)	Predicate Device Performance (Horizon Steri-Lub Lubrication Gel)
Classification Product Code	KMJ	KMJ
Intended Use: Lubricating Device Insertion	Yes	Yes
Prescription Use	Yes	Yes
Sterility	Yes (terminally gamma sterilized)	Yes
Shelf Life	2 years	2 years
Chemical Composition	Water, Glycerin, Polyacrylic Acid, Propylene Glycol, Sodium Polyacrylate preserved with methyl and propyl paraben and sodium metabisulfite	Water, Glycerin, Polyacrylic Acid, Propylene Glycol, Sodium Polyacrylate preserved with methyl and propyl paraben and sodium metabisulfite
Mechanism of Dispensing	10cc Plastic Syringe, Oral Tip	10cc Plastic Syringe, Oral Tip
Barrel, Plunger, Tip Cap Material	Polypropylene	Polypropylene
Plunger Grommet Material (Latex-Free)	Not made with natural rubber latex	Not made with natural rubber latex
Syringe Seal Integrity	Remained sealed when exposed to a 15 In-Hg vacuum.	(Not specified for predicate, but Nurse Assist device met this criterion)
Stain Testing	Post sterile lubricant did not stain gloves.	(Not specified for predicate, but Nurse Assist device met this criterion)
Viscosity	Post sterile lubricant remained within the pre-sterile 18,000 to 26,500 cps viscosity range.	(Nurse Assist device met this criterion against its own pre-sterile range, implying it's consistent)
Volume after Accelerated Aging	Remained within specification.	(Nurse Assist device met this criterion)
pH after Accelerated Aging	Remained within specification.	(Nurse Assist device met this criterion)
Sterility after Accelerated Aging	Remained within specification.	(Nurse Assist device met this criterion)
Biocompatibility	Complied with the requirements of ISO 10993.	(Nurse Assist device met this criterion)

Study Details

This submission relies on non-clinical performance data and a comparison to a predicate device to demonstrate substantial equivalence, rather than a clinical study the way an AI/software device would.

Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to samples of the device undergoing various performance tests (e.g., syringe seal, stain, viscosity, accelerated aging, biocompatibility). The number of units tested for each specific non-clinical test is not provided in this summary. The data provenance is from internal testing conducted by Nurse Assist Incorporated.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical performance tests is established through standardized testing protocols (e.g., ISO 10993 for biocompatibility, physical property measurements for viscosity, pH, volume, etc.), not expert consensus in the diagnostic sense.
Adjudication method: Not applicable. Standard laboratory testing procedures would be followed.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an MRMC study. This device is a pre-filled lubricant syringe, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
The type of ground truth used: For the non-clinical performance tests, the "ground truth" is defined by established scientific and regulatory standards (e.g., specific viscosity ranges, pH levels, sterility tests, ISO 10993 for biocompatibility) that the device must meet.
The sample size for the training set: Not applicable. There is no AI training set.
How the ground truth for the training set was established: Not applicable. There is no AI training set.

Summary

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KI 2290

510(k) Section 5 Pre-filled Lube Jel Syringe

AUG 1 0 2012

5 - 510(k) Summary

(In accordance with 21 CFR 807.87(h) and 21 CFR 807.92)

1. Submitter's name and address: Nurse Assist Incorporated 3400 Northern Cross Boulevard Fort Worth, Texas 76137.
1. Submitter's telephone number and fax number: Tel: (817) 231-1300 Fax: (817) 231-1500

3. Contact person: Bill Kanewske - Vice President of Operations

1. Date this 510(k) summary prepared: 04/27/2012
1. Trade/proprietary name of the device: Sterile Lube Jelly Pre-Filled Syringe

6. Device classification

Classification Name - Patient Lubricant (21 CFR 880.6375) Class 1 Product code KMJ

1. Legally marketed predicate devices to which substantial equivalence is claimed: Steri-Lub Lubrication Gel; Horizon Medical. Inc. - K944969

8. Description of the device that is the subject of this premarket notification:

1. Intended use and indication for use:
  For Prescription Use: For easing the insertion of medical devices such as scopes and catheters into body orifices.

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510(k) Section 5 Pre-filled Lube Jel Syringe

10. Technological characteristics:

A comparison between the Nurse Assist Lube Jelly Pre-Filled Syringe and the Horizon Lube Jelly Pre-Filled Syringe is provided in the table below.

	Nurse Assist LubeJelly Pre-FilledSyringe	Horizon, Steri-LubLubrication Gel
ClassificationProduct Code	KMJ	KMJ
Intended use:LubricatingDeviceInsertion	X	X
Prescription	X	X
Sterile?	Yes	Yes
Shelf life	2 years	2 years
Chemicalcomposition	Water, Glycerin,Polyacrylic Acid,Propylene Glycol, andSodium Polyacrylatepreserved with methyland propyl parabenand sodiummetabisulfite	Water, Glycerin,Polyacrylic Acid,Propylene Glycol, andSodium Polyacrylatepreserved with methyland propyl parabenand sodiummetabisulfite
Mechanism ofdispensing	10cc Plastic Syringe,Oral Tip	10cc Plastic Syringe,Oral Tip
Barrel, Plunger,Tip Cap Material	Polypropylene	Polypropylene
PlungerGrommetMaterial	This product is notmade with naturalrubber latex	This product is notmade with naturalrubber latex

11. Non-Clinical Performance Data

Sterile Lube Jelly Pre-Filled Syringe, product number 1104, is packaged in a 10cc syringe. Testing was performed to demonstrate that the syringe remained sealed when exposed to a 15 In-Hg vacuum.

Stain testing was conducted on post sterile product. Testing was performed to demonstrate that the post sterile lubricant did not stain gloves.

Viscosity testing was conducted on post sterile product. Testing was performed to demonstrate that the post sterile lubricant remained within the pre-sterile 18,000 to 26,500 cps viscosity range.

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K121390

510(k) Section 5 Pre-filled Lube Jel Syringe

Volume, pH and sterility testing were conducted on post sterile aged product. Testing was performed to demonstrate that the product characteristics remained within specification after the product was exposed to accelerated aging. Biocompatibility testing was conducted on post sterile product. Testing was conducted to demonstrate compliance with the requirements of ISO 10993.

12. Substantially Equivalent

The above summarized characteristics and performance testing demonstrated similarities to the predicate Horizon Pre-filled Lube Jelly Syringe. In summary the Nurse Assist Pre-filled Lube Jelly Syringe described in this submission is substantially equivalent to the predicate device.

This concludes the 510(k) Summary

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG 1 0 2012

Mr. Bill Kanewske Vice President of Operations Nurse Assist Incorporated 3400 Northern Cross Boulevard Fort Worth. Texas 76137

Re: K121390

Trade/Device Name: Pre-Filled Lube Jel Syringe Regulation Number: 21 CFR 880.6375 Regulation Name: Patient Lubricant Regulatory Class: I Product Code: KMJ Dated: July 3, 2012 Received: July 10, 2012

Dear Mr. Kanewske:

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 mendments, 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 upprovial approvisions of the Act. The general controls provisions of the Act include controls provisions of the sistration, 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 (1 wirt), it thay of basyone 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- Mr. Kanewske

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 (OS) 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A. 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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510(k) Section 4 Pre-filled Lube Jel Syringe .

4 - Indications for Use

510(k) Number (if known): K / 2/390 Unknown – not yet assigned by FDA

Device Name: Pre-filled Lube Jel Syringe

Indications for Use:

For Prescription Use:

For easing the insertion of medical devices such as scopes and catheters into body orifices.

Prescription Use Over-The-Counter Use X - AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ridd Chopir 8/31/12

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K121390

Page | of | (Posted November 13, 2003)

Regulation Number and Section

§ 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.