(69 days)
Not Found
Not Found
No
The summary describes a kit of standard medical devices used for a specific catheter placement technique and does not mention any AI or ML components.
No.
The device is an accessory kit designed for the placement and/or exchange of peripherally inserted catheters, not for treating any specific disease or condition itself.
No
The device is designed for the placement and exchange of catheters, which is a therapeutic or interventional procedure, not a diagnostic one. It facilitates access to veins but does not gather information for diagnosis.
No
The device description explicitly lists multiple hardware components (catheters, scalpel, measuring tape, drapes, scissors, needle holder, syringe, sheath dilator, guide wire).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The L-Cath Modified Seldinger Technique Accessory Kit is a collection of tools used to facilitate the physical placement of a catheter into a vein. It is a procedural device used on the patient, not a test performed on a sample from the patient.
- Intended Use: The intended use clearly states it's for "placement and/or exchange of the L-Cath Peripherally Inserted Catheter System". This is a medical procedure, not a diagnostic test.
- Device Description: The components listed (catheters, scalpel, measuring tape, etc.) are all instruments used in a surgical or procedural setting.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the L-Cath Modified Seldinger Technique Accessory Kit falls under the category of a medical device used for a procedural purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The L-Cath Modified Seldinger Technique Accessory Kit is designed for placement and/or exchange of the L-Cath Peripherally Inserted Catheter System in 16 ga. (5Fr.), 18 ga. (4Fr.), 20 ga. (3Fr.), 24 ga. (2.6 Fr.) and the L-Cath Dual Lumen 16 and 18 ga. Utilization of a Modified Seldinger Technique for catheter placement has been demonstrated to be effective for the placement of peripherally inserted central catheters in patients, pediatric and adult, with difficult to access veins.
Product codes
79KGZ, FOZ
Device Description
The L-Cath Modified Seldinger Technique Kit consists of over-the-needle insertion catheters, a scalpel, measuring tape, sterile drapes, scissors, needle holder, syringe, with a sheath dilator and guide wire, in appropriate sizes to accommodate the Luther Medical line of Peripherally Inserted Catheters, the "parent devices". Included in the kit are appropriate accessories to aid in this technique.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric and adult
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)
Testing of the OD of the guide wire through the ID of existing Luther Medical catheters has proven to be accurate and appropriate for this application. Biocompatibility testing was completed on the guide wire of similar size in another 510(k) for Silicone catheters.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5200 Intravascular catheter.
(a)
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.(b)
Classification. Class II (performance standards).
0
LUTHER MEDICAL PRODUCTS, INC.
14332 CHAMBERS ROAD TUSTIN, CALIFORNIA 92780-6912
(714) 544-3002 FAX (714) 544-7273
K97 4543
Page 1 of 3
FEB 1 0 1998
GENERAL INFORMATION:
| Applicant's Name and
Address | Luther Medical Products, Inc.
14332 Chambers Road
Tustin, CA 92780-6912
Phone: (714) 544-3002
FAX: (714) 544-7273 |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Barbara C. Luther
Voice Mail: (714) 544-3002 Ext. 227
Phone: (714) 646-5183
FAX: (714) 650-1492 |
| Date of Summary: | August 24, 1997 |
| Common/Usual Name: | Catheter Guide Wire Kit |
| Proprietary Name: | L-Cath® Modified Seldinger Technique (MST) Kit |
| Classification Name: | Catheter Guide Wire, Kit
Classification Number: 79KGZ
Class II
§848.4200 |
| COMPARISON TO LEGALLY
MARKETED DEVICES: | Arrow, International
HDC, Corporation
Cook Critical Care |
| DEVICE DESCRIPTION: | The L-Cath Modified Seldinger Technique Kit consists of
over-the-needle insertion catheters, a scalpel, measuring
tape, sterile drapes, scissors, needle holder, syringe, with a
sheath dilator and guide wire, in appropriate sizes to
accommodate the Luther Medical line of Peripherally
Inserted Catheters, the "parent devices". Included in the kit
are appropriate accessories to aid in this technique. |
1
SUMMARY:
The contents of the kit are either similar or identical to those devices, with the same intended use, on the market. Luther Medical has smaller neonate/pediatric tubing then the competitors and therefore requires a special guide wire OD to accommodate these catheters. A detail comparison is found on the last page of this summary.
SUBSTANTIAL EQUIVALENCE: The guide wire insertion and/or exchange technique has been available to the medical community for over 17 years. The .018" guide wire is too large for the Luther line of catheters specifically used in pediatric and neonatal care.
Testing of the OD of the guide wire through the ID of existing Luther Medical catheters has proven to be accurate and appropriate for this application.
Biocompatibility testing was completed on the guide wire of similar size in another 510(k) for Silicone catheters.
POTENTIAL COMPLICATIONS:
Extensive studies are available in the scientific literature to address the known complications from an insertion, or exchange, of catheters using the modified Seldinger technique. They include but are not limited to:
Infection Damage to the Intima of the Vein Veno Spasm
Arterial Placement
CONCLUSION:
Difficulty Threading Catheter Bleeding from Site.
Discomfort
Air Emboli
Arrythmias Catheter Emboli
Difficulty Removing Guide Wire Thrombosis
Based on the evidence presented the devices are either essentially similar/or identical materials.
The intended use is the same and therefore the devices are considered substantially equivalent.
2
| Contents in MST KIT | Companies w/ Legally Marketed MST Kit Devices | Luther Medical
Products, Inc. | Arrow
International | HDC | Cook Critical
Care |
|----------------------------------------|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Wire Guide Diameter in
inches | | .018" X 45 , 50, 60,
80 cm
.012" X 45, 50 cm
.010" X 45 cm | .018" X 25 , 33
,85 cm
.025" X 25, 68
cm
.035" X 45, 60,
68 cm | .018" X 80 cm | .018" X 50 cm
.021" X 60 cm
.025" X 60 cm |
| Scalpel | | Yes | Yes | Yes | Yes |
| Intravenous OTN
Introducer/Catheter | | 20 ga. X 2"
22 ga. X 1"
24 ga. X ¾" | No | No | 25 ga.
22 ga. |
| Hypodermic Needle | | 22 ga. X 1" | No | No | No |
| Syringe | | 5cc | Yes | Yes | Yes |
| Introducer Needle | | 21 X 2.75"
w/echogenic tip | | 21 ga
w/echogenic tip | 3.5 Fr.
4.0 Fr.
4.5 Fr.
5.0 Fr. |
| Measuring Tape | | Yes | Yes | Yes | Yes |
| Iris scissor | | Yes | No | No | No |
| Catheter Clamp/Needle
Holder | | Yes | Yes | No | Yes |
| Sheath/Dilator | | 3, 4, & 5 Fr. | 5, 5.5, & 7 Fr. | 5 Fr. | 4 Fr.
5 Fr.
7 Fr. |
| Sterile Drape | | Yes | Yes | No | No |
| MST Introducer Kit | | All of the above.
Catheters and
Procedural items are
provided separately
as L-Cath, Single
and DuaL-Cath
PICC Catheters. | All of the above
plus catheters and
procedural
accessories and
drugs. | One 21 ga
introducer
needle with
echogenic tip,
One 0.18"
floppy guide
wire (80cm) and
One
Sheath/Dilator
assembly | All of the above
plus catheters and
procedural
accessories and
drugs. |
| Labeling and Directions
for Use | | Available Upon
Request | Submitted
w/510(k) | Submitted
w/510(k) | Submitted
w/510(k) |
Components of Luther Medical Products, Inc. MST Kits and Companies w/ Legally Marketed MST Kit Devices
Luther Medical Products, Inc. 510(k) Modified Seldinger Technique Kit 08/24/97
:
3
Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health & Human Services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Barbara C. Luther Requlatory Affairs Luther Medical Products, Incorporated 530 Kings Road 92663-5710 Newport Beach, California
FEB 1 0 1998
K974543 Re : L-CATH Modified Seldinger Technique Trade Name: Insertion/Catheter Exchange Kit Regulatory Class: II Product Code: FOZ Dated: August 4, 1997 Received: December 3, 1997
Dear Ms. Luther:
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 of the Act. However, you are responsible to determine that the medical devices you use as components in the L-Cath Modified Seldinger Technique Insertion/Catheter Exchange Kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your ...... L-CATH Modified Seldinger Technique Insertion/Catheter Exchange Kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practice, and 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 Page 2 - Ms. Luther
4
regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, the Food and Drug Administration (FDA) action. may publish further announcements concerning your device in the Federal Register. Please note: this response to your 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.
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 the labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation 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 (800) 638-2041 or (301) 443-6597, or at its internet address "dsmo@fdadr.cdrh.fda.gov".
Sincerely yours,
My Anturat
Timot W A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number: K974543
L-CATH MODIFIED SELDINGER TECHNIQUE Device Name: INSERTION/CATHETER EXCHANGE KIT
INDICATIONS FOR USE:
"Statement of Indications for Use"
The L-Cath Modified Seldinger Technique Accessory Kit is designed for placement and/or exchange of the L-Cath Peripherally Inserted Catheter System in 16 ga. (5Fr.), 18 ga. (4Fr.), 20 ga. (3Fr.), 24 ga. (2.6 Fr.) and the L-Cath Dual Lumen 16 and 18 ga.
Utilization of a Modified Seldinger Technique for catheter placement has been demonstrated to be effective for the placement of peripherally inserted central catheters in patients, pediatric and adult, with difficult to access veins.
Patricin Cusack
X Prescription Use
Section D
Additional Page 2A
December, 1997