JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK & PLANECTA ADAPTOR

K023668 · Jms North America Corp. · FPA · Jul 1, 2003 · General Hospital

Device Facts

• Record ID: K023668
• Device Name: JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK & PLANECTA ADAPTOR
• Applicant: Jms North America Corp.
• Product Code: FPA · General Hospital
• Decision Date: Jul 1, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

JMS Extension Set with Planecta™, Planecta™ (stand alone unit) and Planecta™ Lock / Adaptor are accessories and to be used with a primary vascular access device for fluid administration and blood sampling. Planecta™ with a luer slip syringe or male luer connector to allow needle-less access to the vascular path for injection or withdrawal of fluids or blood. Planecta™ Lock / Adaptor will be used as an adaptor for connection with luer lock syringe or other lock-connecting devices. These device accessories are intended for single use only. JMS Extension Set with Planecta™ (stand alone unit) and Planecta™ Lock / Adaptor will reduce the risk of accidental needle stick injury as a needle will not be used or required throughout the procedure for injection or withdrawal of fluid.

Device Story

JMS Extension Set with Planecta™ system comprises extension sets, stand-alone units, locks, and adaptors; functions as needle-less access interface for primary vascular access devices. Input: fluid or blood via luer slip/lock syringes or connectors. Operation: mechanical fluid path connection; enables needle-less injection/withdrawal. Output: established vascular access path. Used in clinical settings by healthcare professionals. Benefit: reduces risk of accidental needle stick injuries by eliminating need for needles during fluid/blood procedures. Single-use design.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Intravascular administration set accessories. Materials: unspecified medical-grade plastics. Connectivity: mechanical luer slip/lock interfaces. Energy source: none (passive). Form factor: extension tubing, connectors, and adaptors. Sterilization: unspecified. Software: none.

Indications for Use

Indicated for use as accessories to primary vascular access devices for fluid administration and blood sampling in patients requiring intravenous access. Facilitates needle-less injection or withdrawal of fluids/blood. Contraindications: Not for use where needle-based access is required.

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2003 JUL 1

Mr. Swee Cheau Chong Manager, Regulatory Affairs & Quality Assurance JMS North America Corporation Regulatory Affairs 22320 Foothill Boulevard, Suite 350 Hayward, California 94541

Re: K023668

Trade/Device Name: JMS Extension Set with Planecta™, Planecta™ (stand Alone unit), Planecta™ Lock & Planecta™ Adaptor Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: May 8, 2003 Received: May 9, 2003

Dear Mr. Chong:

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.

{1}------------------------------------------------

## Page 2 - Mr. Chong

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 yours,

Susan Runner, DDS, MA

Susan Runner, DDS, Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## achment D

## INDICATIONS FOR USE STATEMENT

## 510(K) Number:

Device Name : JMS Extension Set with Planecta™ (stand alone unit), Planecta™ Lock & Planecta™ Adaptor Product Class / Classification : Class II Product Code : FPA Requlation Number : CFR 21 - 880.5440

Indications For Use: JMS Extension Set with Planecta™, Planecta™ (stand alone unit) and Planecta™ Lock / Adaptor are accessories and to be used with a primary vascular access device for fluid administration and blood sampling. Planecta™ with a luer slip syringe or male luer connector to allow needle-less access to the vascular path for injection or withdrawal of fluids or blood. Planecta™ Lock / Adaptor will be used as an adaptor for connection with luer lock syringe or other lock-connecting devices. These device accessories are intended for single use only.

JMS Extension Set with Planecta™ (stand alone unit) and Planecta™ Lock / Adaptor will reduce the risk of accidental needle stick injury as a needle will not be used or required throughout the procedure for injection or withdrawal of fluid.

(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 Section 801.109)

OR

Over-The-Counter Use

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

510(k) Number: 4,023668