(87 days)
The InCare Pre-lubricated Intermittent Catheter is indicated for use by male, female and pediatric patients for the purpose of bladder drainage. The Catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract.
The InCare Advance and Advance Plus Intermittent Catheters are pre-lubricated with gel to promote easy insertion and user convenience. The catheter gel is contained in an integral reservoir, which eliminates gel migration throughout the package. The InCare Advance and Advance Plus catheters are sterile, non-latex, polyvinyl chloride catheters. A unique manufacturing process ensures that the eyes of the intermittent catheters are polished and smooth to help eliminate trauma to the urethra, reducing the possibility of hematuria. The catheter packaging has been designed to facilitate easy opening for those users with limited dexterity. Both catheters incorporate a no-touch design, which enables the user to easily insert the catheter without direct hand contact, thus reducing the possibility of contamination. The InCare Advance Plus Intermittent Catheter has an introducer tip that is intended to reduce reoccurring UTI and a collection bag to contain urine. The InCare Advance Plus is also available in a kit known as InCare Advance Plus Kit. The InCare Advance and Advance Plus pre-lubricated intermittent catheters are available in various sizes and with a straight or coude tip to accommodate a wide range of male, female, and pediatric end users.
The provided text is a 510(k) Summary for the InCare Pre-lubricated Intermittent Catheters. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific performance acceptance criteria through a clinical study. Therefore, much of the requested information (acceptance criteria, study details, sample sizes, expert involvement, ground truth, effect size with AI assistance, etc.) is not typically included or required in a 510(k) Summary for a device like this.
The 510(k) summary focuses primarily on:
- Identifying the device and its intended use.
- Comparing its technological characteristics to legally marketed predicate devices.
- Demonstrating biocompatibility through established guidelines and standards.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria for device performance. The primary "acceptance" relies on demonstrating substantial equivalence to predicate devices, meaning it works similarly (design, materials, intended use) and addresses basic safety (biocompatibility).
- Reported Device Performance: Instead of performance metrics, the document describes features designed for performance and safety:
- Pre-lubricated with gel for easy insertion and user convenience.
- Gel contained in an integral reservoir to prevent migration.
- Sterile, non-latex, PVC material.
- Polished and smooth eyes to prevent urethral trauma and hematuria.
- Packaging designed for easy opening for users with limited dexterity.
- No-touch design to reduce contamination.
- InCare Advance Plus has an introducer tip to reduce recurring UTIs and a collection bag.
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 describe a clinical "test set" or a study involving human subjects to evaluate these performance characteristics. The assessment primarily relies on a biocompatibility assessment based on established principles and guidelines (United States Pharmacopoeia, G95-1, ISO 10993-1). This is a non-clinical evaluation of the materials.
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 as there was no clinical test set or ground truth established by experts in the context of device performance in humans. The "ground truth" for biocompatibility would be the results of standard biocompatibility tests interpreted by toxicologists or materials scientists, but these details are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as there was no clinical test set requiring adjudication.
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 device is an intermittent catheter, not an AI-powered diagnostic tool. MRMC studies are used for evaluating diagnostic imaging systems, often involving AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For biocompatibility, the "ground truth" is based on the results of standardized biological safety tests (e.g., cytotoxicity, sensitization, irritation) and their comparison against established thresholds and guidelines mentioned (USP, ISO 10993-1). There is no mention of expert consensus, pathology, or outcomes data in the context of a clinical study for this 510(k).
8. The sample size for the training set
- Not applicable. This device is not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI model, so there is no "training set" or ground truth established for it.
In summary, the provided document outlines a 510(k) submission focused on demonstrating substantial equivalence and biocompatibility, not comprehensive performance criteria through clinical studies. The "study" mentioned is a "biocompatibility assessment" based on established regulatory guidelines and standards rather than a clinical trial with human subjects and performance metrics.
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Hollister Incorporated 2000 Hollister Drive Libertyville, Illinois 60048-3781 Telephone: 847.680.1000 Facsimile: 847.918.3860
KOI 3483
Page 1 of 2
JAN 1 4 2002
lollister
Pre lubricated Intermittent Catheter
510(k) Summary
1. Sponsor's name, Address and Contact Person
Sponsor Hollister Incorporated 2000 Hollister Drive Libertyville IL. 60048 Contact Person Joseph S. Tokarz Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 (847) 680-2849 Ph: (847) 918-3860 Fax:
Date Summary Prepared - October 17, 2001
2. Name of Device:
InCare Pre lubricated Intermittent Catheters
3. Name of Predicate Device(s)
| Self-Cath Plus by Mentor | K003784 |
|---|---|
| InstantCath by MTG | K973120 |
| MMG/O'Neil by Rusch | K010420 |
| Self Cath CS by Mentor | K003873 |
4. Description of Device
The InCare Advance and Advance Plus Intermittent Catheters are pre-lubricated with gel to promote easy insertion and user convenience. The catheter gel is contained in an integral reservoir, which eliminates gel migration throughout the package. The InCare Advance and Advance Plus catheters are sterile, non-latex, polyvinyl chloride catheters. A unique manufacturing process ensures that the eyes of the intermittent catheters are polished and smooth to help eliminate trauma to the urethra, reducing the possibility of hematuria.
The catheter packaging has been designed to facilitate easy opening for those users with limited dexterity. Both catheters incorporate a no-touch design, which enables the user to easily insert the catheter without direct hand contact, thus reducing the possibility of contamination.
The InCare Advance Plus Intermittent Catheter has an introducer tip that is intended to reduce reoccurring UTI and a collection bag to contain urine. The InCare Advance Plus is also available in a kit known as InCare Advance Plus Kit.
The InCare Advance and Advance Plus pre-lubricated intermittent catheters are available in various sizes and with a straight or coude tip to accommodate a wide range of male, female, and pediatric end users.
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Pre lubricated Intermittent Catheter
KO13483
Image /page/1/Picture/1 description: The image shows the Hollister logo. The logo consists of a stylized cross-like symbol on the left and the word "Hollister" in a serif font on the right. The logo is in black and white.
5. Statement of Intended Use
The InCare Pre lubricated Intermittent Catheters are indicated for use by male, female and pediatric patients for the purpose of bladder drainage. The Catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract.
6. Statement of Technological Characteristics of the Device
The InCare Pre lubricated Intermittent catheter is substantially equivalent to the predicate devices in design, materials used, and intended use. The Intermittent Catheters are made of a PVC material that is substantially equivalent to the predicate devices.
Biocompatibility assessment of the InCare Pre lubricated Intermittent Catheters has been conducted based on the principles and guidelines established by various governmental regulatory agencies and standard setting organizations. Among these are the following: United States Pharmacopoeia. General program memorandum #G95-1, United States Food and Drug Administration Office of Device Evaluation and The International Standards Organization ISO 10993-1 Biological Evaluation of Medical Devices. Based upon the results of this assessment, the materials used to fabricate the InCare Pre lubricated Intermittent Catheters are considered biocompatible and appropriate for their intended use.
7. Conclusion
Based on information presented above and in the body of this premarket notification the InCare Pre lubricated Intermittent catheters are substantially equivalent to devices currently in distribution.
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville . MD 20850
JAN 1 4 2002
Mr. Joseph S. Tokarz Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive LIBERTYVILLE IL 60048-3781 Re: K013483 Trade/Device Name: Hollister InCare Prelubricated Intermittent Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Codes: 78 KOD and FCM Dated: October 17, 2001 Received: October 18, 2001
Dear Mr. Tokarz:
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 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.
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.
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Page 2
This letter will allow you to begin marketing your device as described in your 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 one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Nancy Cbrogdon
Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Pre lubricated Intermittent Catheter
013483
b. Statement of Intended Use
| 510(k) Number (if Known): | K013483 |
|---|---|
| Device Name: | InCare Pre-lubricated Intermittent Catheter |
Indications For Use:
The InCare Pre-lubricated Intermittent Catheter is indicated for use by male, female and pediative patients for the purpose of bladder drainage. The Catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) OR
Over-the-Counter-Use
(Optional Format 1-2-96)
Jevin A. Simpson
510(k) Numb
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.