(50 days)
The Kendall FAST-CATH Pre-Lubricated Urethral Catheter is intended for sterile intermittent catherization for urine drainage from the bladder.
The Kendall FAST-CATH Pro-Lubricated Urethral Catheter is a sterile, single use system designed for the sterile intermittent cathererization for urine drainage from the bladder. The system is designed for use in both male and female patients. The system consists of a 1200cc plastic collection bag. A 14 Fr rubber or vinyl urological catheler is self contained within the collection bag. A pre-lubricated introducer up allows the catheter to be advanced through the top of the collection bag to perform wrinary cathelestization. A removable cover guards the introducer tip prior to use to maintain sterility.
The Kendall FAST-CATH Pre-Lubricated Urethral Catheter is a sterile, single-use system designed for intermittent catheterization for urine drainage. The provided documentation does not include explicit acceptance criteria with numerical targets. Instead, the testing focuses on demonstrating equivalence to predicate devices and adherence to general medical device standards.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit/General) | Reported Device Performance |
|---|---|---|
| Material Biocompatibility | No toxic diffusible substances (ISO-10993 compliance) | "Testing found the materials contained no toxic diffusible substances." |
| Functional Equivalence | Similar flow rates, shaft stiffness, and other attributes to predicate devices | "Testing demonstrated equivalence between the proposed catheter system and commercially available intermittent urological catheterization systems." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the biocompatibility or functional testing in terms of the number of individual devices or tests performed. The data provenance is not explicitly stated "country of origin" or "retrospective/prospective," but given the nature of the tests (biocompatibility and functional testing), they would typically be prospective laboratory studies conducted by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This type of information is not applicable to this submission. The tests described (biocompatibility and functional performance) are objective laboratory measurements, not subjective evaluations requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert opinions on subjective data, which is not the case here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks involving human readers, which is not the function of a urinary catheter.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable. "Standalone" performance generally refers to AI algorithms performing a task without human intervention. The Kendall FAST-CATH is a medical device, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth for the non-clinical testing was based on:
- Biocompatibility Standards: Compliance with ISO-10993, which defines acceptable biological responses of medical devices.
- Predicate Device Performance: Performance metrics (like flow rates, shaft stiffness) observed from commercially available predicate urinary catheterization systems. This implies that the 'ground truth' for functional performance was defined by the established performance of existing equivalent devices.
8. The Sample Size for the Training Set
This information is not applicable. The Kendall FAST-CATH is a physical medical device, not a machine learning model, and therefore does not have a "training set" in the computational sense. The design and manufacturing processes are informed by engineering principles and standards, not data training.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no "training set" for this type of device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets the (implicit) acceptance criteria is described under "7. Nonclinical Testing":
- Biocompatibility Testing: Performed on the catheter system following ISO-10993 Biological Evaluation of Medical Devices. The results "found the materials contained no toxic diffusible substances." This demonstrates compliance with established safety standards.
- Functional Testing: Performed to determine parameters such as "flow rates, shaft stiffness and other attributes." The results "demonstrated equivalence between the proposed catheter system and commercially available intermittent urological catheterization systems." This establishes that the device performs functionally comparably to legally marketed predicate devices.
The acceptance criteria are implicitly met by demonstrating compliance with international biocompatibility standards and functional equivalence to predicate devices, rather than through specific numerical thresholds. The submission relies on the concept of substantial equivalence under 510(k) regulations, where a new device is found to be as safe and effective as a legally marketed predicate device.
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K973546
102
EXHIBIT 8
510(k) Summary
NOV - 7 1997
Kendall FAST-CATH Pre-Lubricated Urethral Catherer
In accordance with Section 513(1) of the SMDA and as described in 21 CFR Part 807.3 Final Rule dated December 14, 1994, this Summary is submitted by:
Kendail Healthcare Products Company 15 Hampshire Street Mansfield, MA 02048
Date: September 15, 1997
Contact Person 1.
Paul W. Evans Manager, Regulatory Affairs Phone: (508) 261-8203
Name of the Device 2.
Urological Catheter and accessories Classification Name: Pre-Lubricated Urethral Catheter Common or Usual Name: Kendall FAST-CATH Pre-Lubricated Proprietary Name: Urethral Catheter
Statement of Substantial Equivalence నా
The Kendall PAST-CATH Pre-Lubricated Urethral Catheter is substantially equivalent in intended use, design, and function to the commercially marketed MMG O'Neil Urinary Catheterization System, 510(k) No. K910022, and the Bard Touchless Plus Unisex Pre-Lubricated Urethral Catheter.
Description of Device ರ್
The Kendall FAST-CATH Pro-Lubricated Urethral Catheter is a sterile, single use system designed for the sterile intermittent cathererization for urine drainage from the bladder. The system is designed for use in both male and female patients.
The system consists of a 1200cc plastic collection bag. A 14 Fr rubber or vinyl urological catheler is self contained within the collection bag. A pre-lubricated introducer up allows the catheter to be advanced through the top of the collection bag to perform wrinary cathelestization. A removable cover guards the introducer tip prior to use to maintain sterility.
Device Intended Use ਹੋਂ
The Kendall FAST-CATH Pre-Lubricated Urethral Catheter is intended for sterile intermittent catherization for urine drainage from the bladder.
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长973544 2012
6. Product Comparison
The Kendall FAST-CATH Pre-Lubricated Urethral Catherer is equivalent to the referenced predicate devices in that they are similar in design, fabricated from similar materials, have the same function, and identical indications for use.
7. Nonclinical Testing
Biocompatibility testing was performed on the catherer system following ISO-10993 Biological Evaluation of Medical Devices. This testing found the materials contained no toxic diffusible substances.
Functional testing was performed to determine flow rates, shaft stifferss and other attributes. Testing demonstrated equivalence between the proposed cathetor system and commercially available intermittent urological catheterization systems.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 7 1997
Mr. Paul W. Evans Manager, Regulatory Affairs Kendall Healthcare Product Company 15 Hampshire Street Mansfield, Massachusetts 02048
Re: K973546
Kendall FAST-CATH Pre-Lubricated Urethral Catheter Dated: September 15, 1997 Received: September 18, 1997 Regulatory class: II 21 CFR §876.5130/Product code: 78 EZD
Dear Mr. Evans:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, subject to the general controls provisions of 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
W.Lilian Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| S 10fk) Number (if known): | K973546 |
|---|---|
| ---------------------------- | --------- |
Kendall Fast-Cath Pre-Lubricated Urethral Catheter
Device Name:
Sterile intermittent Catheterization for Urine Drainage from Indications For Use:
1 .
the bladder.
W THIS LINE - CONTINUE ON ANOTHER. PAGE IF NEEDED) (PLEASE DO NOT WRITE BEL
DRH, Office of Device E
Robert R Ratting/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K973546
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
::
(Optional Formal 1-2-96)
§ 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.