LMT-KATH-S; LMT-KATH-I

K062308 · Licher Medizintechnologie GmbH · FPA · Mar 20, 2007 · General Hospital

Device Facts

• Record ID: K062308
• Device Name: LMT-KATH-S; LMT-KATH-I
• Applicant: Licher Medizintechnologie GmbH
• Product Code: FPA · General Hospital
• Decision Date: Mar 20, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Infusion Sets are indicated for the infusion and/or injection of medication that is dispensed by means of micro-dosage pump into the body below the surface of the skin. These sets are intended to be used with manual injection and infusion and automated infusion with infusion pumps.

Device Story

Subcutaneous infusion sets (LMT-KATH-S/I) deliver medication from a reservoir to subcutaneous tissue. Components include stainless steel cannula, polyethylene tubing, and circular disk bandage with medical-grade adhesive. Features female Luer connector for reservoir attachment and disconnect mechanism 60cm from insertion site; includes protector cap for clean disconnection. Used in clinical or home settings for medication delivery via manual injection or automated micro-dosage infusion pumps. Provides a pathway for medication administration; benefits patient by enabling controlled subcutaneous delivery.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: stainless steel cannula, polyethylene tubing, medical-grade adhesive. Design: subcutaneous infusion set with female Luer connector, 60cm tubing, and circular disk bandage. Sterilization: not specified. Connectivity: none (mechanical).

Indications for Use

Indicated for subcutaneous infusion and/or injection of medication dispensed via micro-dosage pump. Intended for use with manual injection or automated infusion pumps.

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

• Disetronic Rapid and Rapid D Subcutaneous Infusion Sets (K003977)

Submission Summary (Full Text)

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# 510(k) Notification

MAR 2 0 2007

## Section E. Summary as required by section 807.92 (c)

| Submitter: | Licher Medizintechnologie GmbH<br>Marderweg 1<br>D-30900 Wedemark | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| | Phone | (01149) 5130 - 5855 - 30 |
| | FAX | (01149) 5130 - 5855 - 40 |
| Contact: | Mr. Dieter Mushoff<br>C E O<br>Licher Medizintechnologie GmbH | |
| | Phone | (01149) 5130 - 5855 - 30 |
| | FAX | (01149) 5130 - 5855 - 40 |
| | Email | [e-mail] |
| Date: | 06 / 11 / 2006 | |
| Name of device | LMT-KATH-S 28G 10mm x 60cm /<br>0,394" x 23,62"<br>LMT-KATH-S 28G 8mm x 60cm /<br>0,315" x 23,62"<br>LMT-KATH-I 25G 12mm x 60cm /<br>0,472" x 23,62"<br>LMT-KATH-I 25G 8mm x 60cm /<br>0, 315" x 23,62" | |
| Common name: | Subcutaneous Infusion Sets | |
| Classification<br>name of device: | a) Product code: FPA<br>b) Regulation number: 880.5440 | |
| Predicate device:<br>Sets | Disetronic Rapid and Rapid D Subcutaneous Infusio | |
| | (Premarket Notification K003977) | |
| | Description of the sets: | |
| | Models no. 20500606 and 20500706 | |

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## 510(k) Notification

## Section E. Summary as required by section 807.92 (c)

medical adhesive grade.

The LMT-KATH-S and LMT-KATH-I infusion sets are administration sets intended to deliver medications under the skin. Both connect at the female Luer to a reservoir, which, for example, can be delivered through the use of an external infusion pump or by medical injection. The stainless steel cannula is inserted into the subcutaneous tissue and fixed into place by an attached approximate circular disk bandage with medical grade adhesive. The tubing of both infusion sets is made of polyethylene. The LMT-KATH-S and LMT-KATH-I infusion sets have identical components that allow the set to be disconnected/connected approximately 60 cm / 23.62″ from the insertion site. The disconnect mechanism (Luer connector) on the reservoir side has a protector cap to maintain clean conditions during disconnection and to cover the connector. The tube may have additional bandages with

#### Intended use of the Device:

LMT-KATH-S and LMT-KATH-I Infusion Sets are indicated for the infusion and/or injection of medication that is dispensed by means of micro-dosage pump into the body below the surface of the skin. These sets are intended to be used with manual injection and infusion and automated infusion with infusion pumps.

Comparison of the Technological Features of the New Device and Predicated Device:

The infusion sets "LMT-KATH-S" and "LMT-KATH-I" are substantially similar to the lawfully marketed predicated device. These sets are indicated for the infusion and/or injection of medication that is dispensed by means of microdosage pump into the body below the surface of the skin.

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K 06 6205

### 510(k) Notification MAR 2 0 2007 Section D. Statement of Indications for Use

### Indications for Use Statement

510(k) Number: K062308

Device Name:

LMT-KATH-S 28G 10mm x 60cm / 0,394" x 23,62" LMT-KATH-S 28G 8mm x 60cm / 0,315" x 23,62" LMT-KATH-I 25G 12mm x 60cm / 0,472" x 23,62" 8mm x 60cm / 0,315" x 23,62" LMT-KATH-I 25G

Indications for Use:

LMT-KATH-S 28G 10mm x 60cm / 0,394" x 23,62"

LMT-KATH-S 28G 8mm x 60cm / 0,315" x 23,62"

LMT-KATH-I 25G 12mm x 60cm / 0,472" x 23,62"

LMT-KATH-1 25G 8mm x 60cm / 0,315" x 23,62"

Infusion Sets are indicated for the infusion and/or injection of medication that is dispensed by means of micro-dosage pump into the body below the surface of the skin.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2007

Mr. Dieter Mushoff CEO Licher Medizintechnologie GMBH Marderweg 1 Wedemark, Germany D-30900

Re: K062308

Trade/Device Name: LMT-KATH-S 28G 10mm x 60cm; LMT-KATH -S 28G 8mm x 60cm; LMT-KATH-1 25G 12mm x 60cm; LMT-KATH-I 8mm x 60cm Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: December 11, 2006 Received: January 30, 2007

Dear Mr. Mushoff:

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.

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Page 2 -Mr. Mushoff

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/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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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## 510(k) Notification Section D. Statement of Indications for Use

### Indications for Use Statement

510(k) Number: K062308

Device Name: LMT-KATH-S 28G 10mm x 60cm LMT-KATH-S 28G 8mm x 60cm LMT-KATH-I 25G 12mm x 60cm LMT-KATH-I 25G 8mm x 60cm

Indications for Use: LMT-KATH-S 28G 10mm x 60cm LMT-KATH-S 28G 8mm x 60cm LMT-KATH-I 25G 12mm x 60cm LMT-KATH-1 25G 8mm x 60cm

Infusion Sets are indicated for the infusion and/or iniection of medication that is dispensed by means of micro-dosage pump into the body below the surface of the skin.

Prescription Use _ ਮ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Ried C. Ahyer for tow 3/20/07

n of Anesthasiology, Ganaral Hospital, con Control, Dental Devices

K062308