DOVER ROB-NEL CATHETER

K040897 · Tyco Healthcare · KOD · Jul 20, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K040897
• Device Name: DOVER ROB-NEL CATHETER
• Applicant: Tyco Healthcare
• Product Code: KOD · Gastroenterology, Urology
• Decision Date: Jul 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The product is intended for intermittent catheterization to drain urine from the urinary bladder. The product is intended for use on patients who are not capable of voluntary urination.

Device Story

Sterile, single-use, intermittent urinary drainage catheter; extruded from thermo-sensitive polyvinyl chloride (PVC). Used to drain urine from bladder in patients unable to void voluntarily. Manual operation by clinician or patient. Device facilitates bladder emptying; prevents urinary retention. No electronic or software components.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1 and FDA memorandum G95-1.

Technological Characteristics

Thermo-sensitive polyvinyl chloride (PVC) extrusion; sterile; single-use; intermittent drainage design. Complies with ISO 10993 biocompatibility standards.

Indications for Use

Indicated for intermittent urinary bladder drainage in patients incapable of voluntary urination. Not for use as an indwelling catheter.

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

• DOVER® ROB-NEL Catheter (K810216)

Submission Summary (Full Text)

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## 510 (k) Summary

K040897
Page 1 of 2

# JUL 2 0 2004

In accordance with section 513(I) of the SMDA and as defined in 21 CFR Part 807.3 final rule dated December 14, 1994, this summary is submitted by:

Tyco Healthcare/Kendall 15 Hampshire Street Mansfield, MA 02048 Date Prepared: March 29, 2004

## 1. Contact Person

Wei Zhao Senior Specialist, Regulatory Affairs Tyco Healthcare/Kendall Telephone: [phone] Fax: [phone]

#### 2. Name of Medical Device

Classification Name: Common or Usual Name: Urological catheter and accessories Urinary Drainage Catheter

#### 3. Identification of Legally Marketed Device

The proposed Tyco Healthcare/Kendall DOVER® ROB-NEL Catheter is substantially equivalent in intended use, function and mode of operation to the Tyco Healthcare/Kendall DOVER® ROB-NEL Catheter, which is currently marketed under 510(K) number K810216.

#### 4. Device Description

The Tyco Healthcare/Kendall DOVER® ROB-NEL Catheter is a sterile, single use, Intermittent urinary drainage catheter extruded from thermo-sensitive Polyvinyl chloride (PVC) material.

#### 5. Device Intended Use

The product is intended for intermittent catheterization to drain urine from the urinary bladder. The product is intended for use on patients who are not capable of voluntary urination.

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## 6. Product Comparison

..............................................................................................................................................................................

K040897
Page 2 of 2

The proposed DOVER® ROB-NEL Catheter is substantially equivalent to the predicate device in that each product has the same intended use and same physical, functional and performance characteristics. The proposed and predicate devices are made from the same materials and have the same design.

## 7. Nonclinical Testing

Biocompatibility testing has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1.

End of Document

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 0 2004

Ms. Wei Zhao Senior Regulatory Specialist Tyco Healthcare The Kendall Company 15 Hampshire Street MANSFIELD MA 02048

Re: K040897

Trade/Device Name: Tyco Healthcare/Kendall DOVER® ROB-NEL Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 KOD Dated: June 22, 2004 Received: June 23, 2004

Dear Ms. Zhao:

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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This letter will allow you to begin marketing your device as described in your Section 510(k) I his leter will anow you to begal marked of substantial equivalence of your device to a legally prematication. The PDF and 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 If you desire specific advice to your as the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Audulation of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding Office of Comphanos at (2017-724tion" (21CFR Part 807.97) you may obtain. Other gencral by relection on your responsibilities under the Act may be obtained from the Division of Small Information on your responsional and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Solless http://www.fda.gov/cdrf/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy 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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and the comments of the comments of the comments of

Indication for Use Statement

## 510 (k) Number (if known): K 040897

#### Device Name:

Tyco Healthcare/Kendall DOVER® ROB-NEL Catheter

#### Indications for Use:

The proposed device is intended for use in the drainage of urine from the urinary bladder. The proposed active intermittent catheterization on patients who are not capable of rno production. This product is not designed for use as an indwelling catheter.

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)

Nancy c Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K040897