MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE

K013556 · Tyco Healthcare · FOZ · Dec 31, 2001 · General Hospital

Device Facts

• Record ID: K013556
• Device Name: MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE
• Applicant: Tyco Healthcare
• Product Code: FOZ · General Hospital
• Decision Date: Dec 31, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The proposed device is indicated only for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.

Device Story

Device is a sterile, single-use, standard piston syringe containing Heparin Lock Flush Solution (10 or 100 USP units/ml). Used in clinical settings to flush intravenous administration sets and indwelling intravascular access devices. Operated by healthcare professionals. Provides a pre-filled, ready-to-use delivery mechanism for heparin flush solution to maintain patency of intravascular access devices.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in accordance with ISO 10993, Part 1, and FDA memorandum G95-1.

Technological Characteristics

Sterile, single-use, standard piston syringe. Contains Heparin Lock Flush Solution, USP (10 or 100 USP units/ml). Materials meet ISO 10993 biocompatibility requirements.

Indications for Use

Indicated for flushing compatible intravenous administration sets and indwelling intravascular access devices.

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

• Baxter Healthcare Corporations' Heparin Lock Flush Syringe (K003245)

Submission Summary (Full Text)

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## EXHIBIT # 9

## 510(k) Summary

DEC 31 2001

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: November 26, 2001

- 1. Contact Person
David A. Olson Director, Regulatory Affairs [phone]

- 2. Name of Medical Device
Catheter, Intravascular, Therapeutic, Short-Term Classification Name: Common or Usual Name: Monoject® PreFill Heparin Lock Flush Syringe

- 3. Identification of Legally Marketed Device
The proposed Kendall Monoject® PreFill Flush Syringe is substantially equivalent in intended use, function and composition to Baxter Healthcare Corporations' Heparin Lock Flush Syringe, 510(k) No. K003245.

- 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.

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

- 6. Product Comparison

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The proposed device has the same technological characteristics as the predicate devices. Each consists of Monoject® plastic syringes containing Heparin Lock Flush Solution, USP.

#### 7. Nonclinical Testing

Biocompatibility testing of the proposed device 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.

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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 is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 31 2001

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

Re: K013556

Trade/Device Name: Monojet Pre-Fill Heparin Lock Flush Syringe Regulation Number: 880.5200 Regulation Name: Catheter, Intravascular, Therapeutic, Short-Term Regulatory Class: II Product Code: NGT Dated: October 24, 2001 Received: October 25, 2001

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 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 - Mr. Olson

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 Of K Part 6077; lacemig (21 CFR Part 820); and if applicable, the electronic for an and quinny of eventions (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 promated predicated 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 31 31 594-4618. Additionally, for questions on the promotion and advertising of Compliance at [phone] of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general 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 yours,
Lillatoust

Timoth Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### K 013550

KO13556 510(k) Number (if known):

(ii known):
Monoject Pre Fill Heparin Lock Flush Syringe, 10 and 100 units/m Device Name:_

Indications For Use:

The Heparin Lock Flush Syringe, 10 and 100 units/ml is intended for The ricpanni Lock Pract: Syints, 2001 administration sets and indwelling intravenous access devices.

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div>(Per 21 CFR 801.109)</div> |
|------------------|---------------------------------|
|------------------|---------------------------------|

OR

| Over-The-Counter Use | <div>(Optional Format 1-2-96)</div> |
|----------------------|-------------------------------------|
|----------------------|-------------------------------------|

Vick Hibbard for Pat Cricenti
'Division Sign-Off) Envision of Dental, Infection Control, and General Hospital Devices · Norober KO13556