MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE

K032438 · Tyco Healthcare · NGT · Jun 30, 2004 · General Hospital

Device Facts

• Record ID: K032438
• Device Name: MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE
• Applicant: Tyco Healthcare
• Product Code: NGT · General Hospital
• Decision Date: Jun 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 0.9% Sodium Chloride Flush Syringe is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices. The Heparin Lock Flush Syringe, 10 and 100 units/ml is intended for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.

Device Story

Monoject Prefill Flush Syringes are sterile, single-use, standard piston syringes pre-filled with either 0.9% Sodium Chloride USP or Heparin (10 or 100 USP units/ml). Used in clinical settings to maintain patency of intravenous tubing and indwelling intravascular access devices. Operated by healthcare professionals to flush lines, preventing occlusion or clotting. Device provides a ready-to-use solution, reducing preparation time and potential for contamination compared to manual syringe filling.

Clinical Evidence

No clinical data. Verification testing for the manufacturing process change included microbiological, physical, functional, and product stability testing.

Technological Characteristics

Sterile, single-use, standard piston syringe. Contains 0.9% Sodium Chloride USP or Heparin (10 or 100 USP units/ml).

Indications for Use

Indicated for flushing compatible intravenous tubing systems and indwelling intravascular access devices in patients requiring such maintenance.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• Monoject ParFill Sodium Chloride and Heparin Lock Flush Syringes (K011283)
• Monoject ParFill Sodium Chloride and Heparin Lock Flush Syringes (K013556)

Submission Summary (Full Text)

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JUN 3 0 2004

# EXHIBIT # 7

K032438

Page 1 of 2

## 510(k) Summarv

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:

The Kendall Company 15 Hampshire Street Mansfield, MA 02048 Date Prepared: August 4, 2003

1. Contact Person

> David A. Olson Vice President, Regulatory Affairs [phone]

- 2. Name of Medical Device
Classification Name: Catheter, Intravascular, Therapeutic, Short-Term Common or Usual Name: Monoject® Prefill Flush Syringes

## 3. Identification of Legally Marketed Device

The proposed Kendall Monoject® Prefill Flush Syringes are substantially equivalent in intended use, function and composition to the currently marketed Monoject ParFill Sodium Chloride and Heparin Lock Flush Syringes, 510(k) numbers K011283 and K013556.

#### 4. Device Description

The proposed device is a sterile, single use, standard piston syringe of various sizes and fill volumes containing either 10 or 100 USP Heparin units/ml, or, 0.9% Sodium Chloride USP.

- 5. Device Intended Use
The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.

- 6. Product Comparison

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The proposed device has the same technological characteristics and indical use as the predicate devices. The proposed modification involves a change in the manufacturing process.

### 7. Nonclinical Testing

Verification testing for the proposed change involved microbiological, physical, functional and product stability testing.

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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 features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 0 2004

Tyco Healthcare Mr. David A. Olson Vice President, Regulatory Affairs Kendall 15 Hampshire Street Mansfield, Massachusetts 02048

Re: K032438

Trade/Device Name: Monoject 0.9% Sodium Chloride and Heparin Lock Flush Syringe Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: NGT Dated: April 29, 2004 Received: May 3, 2004

Dear Mr. Olson:

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 such 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 Eederal Register.

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Page 2 - Mr. Olson

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.

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 (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html

Sincerely vours.

Clive

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

510(k) Number (if known):

Device Name: Monoject 0.9% Sodium Chloride and Heparin Lock Flush Syringe

Indications for Use: The 0.9% Sodium Chloride Flush Syringe is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.

The Heparin Lock Flush Syringe, 10 and 100 units/ml is intended for use in flushing compatible intravenous administration sets and industrials and individually

Please Do Not Write Below This Line – Continue On Another Page If Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
Use
(Per 21 CFR 801.109)

OR

Over-The-Counter

Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental

510(k) Number: K032438