(224 days)
Not Found
No
The device description and intended use focus on the mechanical components of an infusion set and do not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device delivers medication, but it is not a therapeutic device itself. Therapeutic devices are those that treat or cure a disease or condition, which this infusion set does not do directly.
No
Explanation: The device is described as an "Infusion Set" used for the "infusion and/or injection of medication." Its function is to deliver medication, not to diagnose a medical condition.
No
The device description clearly details physical components such as cannulas, tubing, bandages, and Luer connectors, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The LMT-KATH-S and LMT-KATH-I Infusion Sets are designed to deliver medication into the body below the skin. They are administration sets for infusion and injection.
- Lack of Specimen Analysis: The description does not mention any analysis of biological specimens. The device's purpose is to introduce substances into the body, not to test substances from the body.
Therefore, based on the intended use and device description, these infusion sets fall under the category of medical devices used for drug delivery, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
FPA
Device Description
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 medical adhesive grade.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
below the surface of the skin.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
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.(b)
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.
0
510(k) Notification
MAR 2 0 2007
Section E. Summary as required by section 807.92 (c)
| Submitter: | Licher Medizintechnologie GmbH
Marderweg 1
D-30900 Wedemark | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| | Phone | (01149) 5130 - 5855 - 30 |
| | FAX | (01149) 5130 - 5855 - 40 |
| Contact: | Mr. Dieter Mushoff
C E O
Licher Medizintechnologie GmbH | |
| | Phone | (01149) 5130 - 5855 - 30 |
| | FAX | (01149) 5130 - 5855 - 40 |
| | Email | lichermt@t-online.de |
| Date: | 06 / 11 / 2006 | |
| Name of device | 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-I 25G 8mm x 60cm /
0, 315" x 23,62" | |
| Common name: | Subcutaneous Infusion Sets | |
| Classification
name of device: | a) Product code: FPA
b) Regulation number: 880.5440 | |
| Predicate device:
Sets | Disetronic Rapid and Rapid D Subcutaneous Infusio | |
| | (Premarket Notification K003977) | |
| | Description of the sets: | |
| | Models no. 20500606 and 20500706 | |
1
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.
2
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)
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.
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.
4
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
5
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