MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT)

K080878 · Medical Technologies of Georgia, Inc. · KOD · Jul 17, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K080878
• Device Name: MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT)
• Applicant: Medical Technologies of Georgia, Inc.
• Product Code: KOD · Gastroenterology, Urology
• Decision Date: Jul 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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.

Device Story

Sterile, single-use, closed-system urinary catheter; pre-lubricated PVC or Red Rubber construction; self-contained in collection bag. Includes silicone introducer tip to minimize contamination during insertion. Deluxe version features 'easy advancer' mechanism to prevent catheter slippage during insertion. Kits include intermittent catheter, PVP swabs/BZK prep pads, gloves, gauze, and underpad. Used by patients or caregivers to drain urine from bladder when commode/bedpan use is not feasible. Device facilitates hygienic catheterization; reduces contamination risk; simplifies advancement for user.

Clinical Evidence

Bench testing only. Comparative performance testing against predicate included flow rate (within +/- 10%), lubricity (exceeded minimum gel quantity), and tensile strength (per EN1616:1997 +A1:1999). All devices passed specification criteria.

Technological Characteristics

Materials: PVC or Red Rubber catheter, silicone introducer tip. Form factor: Closed system with integrated collection bag. Connectivity: None. Sterilization: Sterile. Standards: EN1616:1997 +A1:1999 (tensile strength).

Indications for Use

Indicated for male, female, and pediatric patients requiring urinary bladder drainage.

Regulatory Classification

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).

Predicate Devices

• Apogee Closed System Catheter (K032710)

Submission Summary (Full Text)

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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

- 1) the same intended use Intermittent Catheter inserted into bladder through urethra for emptying the bladder, typically not longer than 5 minutes per catheterization
- 2) 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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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 [phone]

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 [phone]. 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 [phone] or [phone], 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.

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