(108 days)
MTG fustant Cath™, MTG firstant Cath™ 'title (f VF or BZK), MTG finstant Cath 'M Detuxe and MTG Tinstant Cath™ Deluxe kit (PVP or BZK) are intended to be used to drain urine from the patient's bladder.
The MTG Instant Cath™ is a sterile, closed system, single use, disposable, pre-lubricated PVC or Red Rubber (based on user preference for softness both are offered) catheter self-contained in a collection bag. It is used to drain urine from the bladder. When it is not practical or feasible for the patient to drain the bladder into a commode or bedpan, the urine may be drained into the collection bag. The MTG Instant Cath™ is designed with a collection bag and introducer tip for inserting the catheter without having to directly touch the catheter. reducing the possibility of contamination. The MTG Instant Cath 100 Deluxe is the same as the MTG Instant Cath", and includes an easy advancer that will make it less likely for the catheter to slip back into the bag during insertion. The purpose of this easy advancer, which does not come in contact with the patient, is solely to make the device casier for the patient or caregiver to advance the catheter and will in no way affect safety or effectiveness of the device. The MTG Instant Cath™ kit and MTG Instant Cath™ Deluxe kit include the intermittent catheter, with either PVP swabs and/or BZK prep pad/swab, gloves, gauze and an underpad. These roducts will be available in various sizes to accommodate a wide range of male, female and pediatric users.
Here's an analysis of the provided text regarding the acceptance criteria and study for the MTG Instant Cath™:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Flow Rate | Matched predicate within +/- 10% and exceeded specification criteria. |
| Lubricity | Exceeded minimum gel quantity for both predicate and specification criteria. |
| Catheter Tensile Strength | All devices tested passed when evaluated according to EN1616:1997 +A1:1999 Annex A. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each performance test (Flow Rate, Lubricity, Catheter Tensile Strength). It uses phrases like "all MTG devices" and "all samples of MTG Instant Cath™ and MTG Instant Cath™ Deluxe tested," suggesting that a representative number of devices were tested, but precise figures are not given.
The provenance of the data is not specified. It is likely a combination of laboratory testing conducted by the manufacturer. Whether the data is retrospective or prospective is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The performance testing appears to be objective, laboratory-based physical measurements rather than assessments requiring human expert interpretation against a ground truth.
4. Adjudication Method for the Test Set
No adjudication method is mentioned or appears applicable, as the tests are objective physical measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The device is a medical catheter for draining urine, and the performance tests described are focused on physical and functional characteristics, not diagnostic accuracy requiring human-in-the-loop assessment.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the device is a physical medical catheter, not an AI algorithm.
7. Type of Ground Truth Used
The ground truth for the performance tests appears to be:
- Predicate device's performance: For Flow Rate and Lubricity, the performance of the predicate device (Apogee Closed System Catheter K032710) served as a benchmark.
- Established specification criteria: Both Flow Rate and Lubricity exceeded independent specification criteria, though the specifics of these criteria are not detailed.
- International standard: For Catheter Tensile Strength, the ground truth was adherence to the method and passing criteria outlined in EN1616:1997 +A1:1999 "Sterile Urethral Catheters for Single Use" annex A.
8. Sample Size for the Training Set
This is not applicable as the device is a physical medical catheter, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
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Ko 800878 Page 1 of 2
Section 17 - Summary of Safety and Effectiveness
17.1 Sponsor Name Medical Technologies of Georgia, Inc.
JUL 1 7 2008
17.2 Device Name MTG Instant Cath™ MTG Instant Cath™ Deluxe
17.3 Identification of Predicate or Legally Marketed Device Apogee Closed System Catheter K032710
17.4 Device Description
The MTG Instant Cath™ is a sterile, closed system, single use, disposable, pre-lubricated PVC or Red Rubber (based on user preference for softness both are offered) catheter self-contained in a collection bag. It is used to drain urine from the bladder. When it is not practical or feasible for the patient to drain the bladder into a commode or bedpan, the urine may be drained into the collection bag. The MTG Instant Cath™ is designed with a collection bag and introducer tip for inserting the catheter without having to directly touch the catheter. reducing the possibility of contamination. The MTG Instant Cath 100 Deluxe is the same as the MTG Instant Cath", and includes an easy advancer that will make it less likely for the catheter to slip back into the bag during insertion. The purpose of this easy advancer, which does not come in contact with the patient, is solely to make the device casier for the patient or caregiver to advance the catheter and will in no way affect safety or effectiveness of the device. The MTG Instant Cath™ kit and MTG Instant Cath™ Deluxe kit include the intermittent catheter, with either PVP swabs and/or BZK prep pad/swab, gloves, gauze and an underpad. These roducts will be available in various sizes to accommodate a wide range of male, female and pediatric users.
17.5 Intended Use
MTG Instant Cath™, MTG Instant Cath™ kit,, MTG Instant Cath™ Deluxe and MTG Instant Cath™ Deluxe kit are intended to be used to drain urine from the patient's bladder.
17.6 Comparison of Technological Characteristics
The MTG Instant Cath™ kit and MTG Instant Cath™ Deluxe kit and the predicates have
-
- the same intended use Intermittent Catheter inserted into bladder through urethra for emptying the bladder, typically not longer than 5 minutes per catheterization
-
- same technologic characteristics Pre-Jubricated Polyvinylchloride (PVC) or Red Rubber catheter selfcontained in a sterile collection bag with a silicone introducer tip and cap. Both are offered in a variety of sizes and kit component configurations
17.7 Performance Testing
The following performance tests were performed in comparison to the predicate:
Flow rate - all MTG devices were found to have a flow rate that equaled the predicate within +/- 10%. The MTG devices also all exceeded the specification criteria.
Lubricity - all samples of MTG Instant Cath™ and MTG Instant Cath™ Deluxe tested were determined to have exceeded the minimum quantity of gel for both the predicate and the specification criteria.
Catheter Tensile Strength - The tensile strength of the MTG Instant Cath™ and MTG Instant Cath™ Deluxe as evaluated in accordance with EN1616:1997 +A1:1999 "Sterile Urethral Catheters for Single Use" annex A "Test method for determining strength of catheter". All MTG Instant Cath™ and MTG Instant Cath™ Deluxe
devices tested passed.
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K080878 page 272
* 7.8- Statement of Equivalency
n Summary, the MTG Instant Cath™ and MTG Instant Cath™ Deluxe (including kits) have the same intended use as the Apogee Closed System Catheter and Apogee Closed System Catheterization Kit – cleared under 510(k) K032710 - Apogee Medical, Youngsville, NC. The functional performance test performance test performed on both devices show equivalent performance capabilities.
The evaluation of the MTG Instant Cath™ and MTG Instant Cath™ Deluxe (including kits) does not raise any additional concerns regarding safety and effectivity and may therefore be considered substantially evolution to the predicate device.
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Image /page/2/Picture/1 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, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 2008
Ms. Cindi Sartain President Medical Technologies of Georgia, Inc. 15151 Prater Drive, Suite E COVINGTON GA 30014
Re: K080878
Trade/Device Name: MTG Instant Cath™ and MTG Instant Cath™ Deluxe Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: KOD Dated: July 7, 2008 Received: July 8, 2008
Dear Ms. Sartain:
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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: II you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. 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
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Page 2 – Ms. Cindi Sartain
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.
In addition, we have determined that your device kit contains Iodophor PVP Swabsticks which are subject to regulation as a drug.
Our substantially equivalent determination does not apply to the drug component of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component. For information on applicable Agency requirements for marketing this drug, we suggest you contact:
Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101
This letter will allow you to begin marketing your device as described in your Section 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, please contact the Office of Compliance at (240) 276-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (240) 276-3150, or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Herbert Leiner
Image /page/3/Picture/9 description: The image contains two words, "for" and "Now". The word "for" is written in cursive and is located on the left side of the image. The word "Now" is written in print and is located on the right side of the image. The text is black against a white background.
ancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4 - Indications for Use
KOBORTB 0(k) Number (if known):
Device Name: MTG Instant Cath™ MTG Instant Cath™ kit with gloves, underpad, gauze, PVP swabsticks (3) MTG Instant Cath™ kit with gloves, underpad, gauze, BZK prep pad/swab MTG Instant Cath™ Deluxe MTG Instant Cath™ Deluxe kit with gloves, underpad, gauze, PVP swabsticks (3) MTG Instant Cath™ Deluxe kit with gloves, underpad, gauze, BZK prep pad/swab
Indications For Use:
MTG fustant Cath™, MTG firstant Cath™ 'title (f VF or BZK), MTG finstant Cath 'M Detuxe and MTG Tinstant Cath™ Deluxe kit (PVP or BZK) are intended to be used to drain urine from the patient's bladder.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helslessen
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
Page 1 of
§ 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.