MPS HUBER NEEDLE EXTENSION SET

K982047 · Medical Product Specialists · FPA · Jul 21, 1998 · General Hospital

Device Facts

• Record ID: K982047
• Device Name: MPS HUBER NEEDLE EXTENSION SET
• Applicant: Medical Product Specialists
• Product Code: FPA · General Hospital
• Decision Date: Jul 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MPS Huber Needle Extension Set is intended for use with implanted infusion ports for continuous or intermittent infusion therapy. For use for infusion of I.V. fluids, blood, blood products and drugs. Change per CDC guidelines or per hospital Protocol.

Device Story

MPS Huber Needle Extension Set facilitates transdermal infusion via subcutaneous access ports. Device comprises angled non-coring stainless steel needle bonded to microbore infusion tubing, terminating in female luer-lock connector. Includes needle tip protector, luer cap, and color-coded stabilization wings; some configurations include Y-injection sites and clamps. Used in clinical settings for infusion of fluids, blood, and medications. Healthcare providers insert needle into implanted port to establish access. Output is fluid delivery path. Benefits include secure, reliable access to implanted ports for therapeutic administration.

Clinical Evidence

Bench testing only. Plastic components and bonding agents tested per ISO 10993 for biocompatibility. Metals meet ASTM standards.

Technological Characteristics

Non-coring stainless steel needle; microbore infusion tubing; female luer-lock connector. Materials tested per ISO 10993. Metals meet ASTM standards. Sterile, non-pyrogenic. Manual operation.

Indications for Use

Indicated for patients requiring continuous or intermittent infusion therapy via implanted infusion ports, including administration of IV fluids, blood, blood products, and drugs.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• GISH VASTACK®

Submission Summary (Full Text)

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# JUL 2 | 1998

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K 982047

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### 510(k) Summary

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| 1. Submitter: | Medical Product Specialists, Inc. (MPS) 499 Nibus Street, suite E Brea, CA 92821 Tel: [phone] Fax: [phone] |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Contact: | Dan Hyun, President Medical Product Specialists |
| 3. Date prepared: | May 29, 1998 |
| 4. Device trade name: | MPS Huber Needle Extension Set |
| Common name: | Intravenous (IV) Medication Connector and IV Sets Implanted infusion port needle Huber needle |
| 5. Predicate device: | GISH VASTACK® |
| 6. Description: | The MPS Huber Needle Extension Set is a family of sterile and non-pyrogenic devices used for transdermal infusion via subcutaneous access ports. These devices consist of angled non-coring stainless steel needle bonded to microbore infusion tubing ending with a standard female luer connector with luer- lock. Each set is provided with a needle tip protector, luer cap, and color coded stabilization wings. Various configurations may also include Y injection sites, and clamps typically associated with standard microbore tubing infusion sets.<br>Each MPS Huber Needle Extension Set is sterilized in sealed individual pouches or trays. Full labeling information is provided with each MPS Huber Needle Extension Set. Multi- unit shelf packs of individual pouches or trays are provided for convenience. |
| 7. Intended Use: | |
| a. | The MPS Huber Needle Extension Set is intended for use with implanted infusion ports for continuous or intermittent infusion therapy. |
| b. | For use for infusion of I.V. fluids, blood, blood products and drugs. |

Change per CDC guidelines or per hospital Protocol. C.

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#### Technological comparison to predicate device: 8.

The technological characteristics are intended to be substantially equivalent (in materials, design, and intended use) to the devices currently marketed under the trade name Gish VASTACK® .

The design variation is in the needle grip. The Gish VASTACK design is a clear rigid grip with a foam pad for patient comfort. The proposed MPS Huber Needle Extension Set grip incorporates the flexible color coded wings typically present on infusion needle sets, with a raised pattern on the patient contact surface for comfort. This design difference is not expected to effect safety nor effectiveness of the MPS Huber Needle Extension Set in its intended use.

- ல் Nonclinical test summary:
Plastic component materials and bonding agents have been tested per ISO 10993 Biological Testing of Medical and Dental Materials. Testing indicates that materials are safe and biocompatible. Component metals shall meet an ASTM standard where biocompatibility is indicated.

- 10. Conclusion: The MPS Huber Needle Extension Set is substantially equivalent to the legally marketed 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 features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 21 1998

Mr. Dan Hyun ·President Medical Product Specialists, Incorporated 499 Nibus Street, Suite E Brea, California 92821

K982047 Re : MPS Huber Needle Extension Set Trade Name: Regulatory Class: II Product Code: FPA Dated: May 29, 1998 June 10, 1998 Received:

Dear Mr. Hyun:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in this response to your the Federal Register. Please note: premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Hyun

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

s. Butman for

Timothy A. 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 982047

## PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT

(As required by ODE for all 510(k) received after Jan. 1, 1996.)

510(k) Number:

#### MPS Huber Needle Extension Set Device Name:

#### Indications For Use:

- The MPS Huber Needle Extension Set is intended for use with a. implanted infusion ports for continuous or intermittent infusion therapy.
- For use for infusion of I.V. fluids, blood, blood products and b. drugs.
- C. Change per CDC guidelines or per hospital Protocol.

(Do not write below this line. Continue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Palacios Crescent

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

or

510(k) Number 1982047

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

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