(112 days)
Not Found
No
The summary describes a mechanical device for catheter introduction and needlestick prevention, with no mention of AI or ML capabilities.
No
The device is used to facilitate the placement of a catheter and reduce the risk of needlestick, which are procedural functions, not therapeutic.
No
The device is described as an introducer for placing intravenous catheters, which is a therapeutic or procedural function, not a diagnostic one. It facilitates access for treatment, rather than identifying a medical condition or disease.
No
The device description clearly indicates it is a physical medical device (an over-the-needle peel-away plastic sheath catheter introducer) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate the placement of a peripherally inserted intravenous catheter through the skin into a vein. This is a procedure performed directly on a patient for therapeutic or diagnostic purposes (like administering fluids or drawing blood), not for testing samples in vitro (outside the body).
- Device Description: The device is an introducer for a catheter, designed to be inserted into a vein. This is a medical device used for direct patient intervention.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing samples.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Blunt T-Peel Plastic Sheath Introducer is used to facilitate placement of a peripherally inserted intravenous catheter through the skin into a vein and when used according to the Directions For Use, may reduce the risk of an accidental needlestick.
Product codes
DYB
Device Description
An over-the-needle peel-away plastic sheath catheter introducer which includes a blunting feature to blunt the tip of the needle after venous access.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vein
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
The additional needlestick protection feature of the Blunt T-Peel Plastic Sheath Catheter Introducer has been evaluated according to a documented test protocol. All test results were satisfactory and met the protocol's requirements. The activation force was within specified limits. The puncture force with the shielded needle exceeded that with the unshielded needle in all cases. The force to override the needle shielding feature exceeds the minimum requirements.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The T-Peel Plastic Sheath Introducer has been on the market for several years and was previously tested and qualified. There are no design, dimensional or material changes to the device. Therefore no testing of the catheter introduction features are necessary.
The additional needlestick protection feature of the Blunt T-Peel Plastic Sheath Catheter Introducer has been evaluated according to a documented test protocol. All test results were satisfactory and met the protocol's requirements. The activation force was within specified limits. The puncture force with the shielded needle exceeded that with the unshielded needle in all cases. The force to override the needle shielding feature exceeds the minimum requirements.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
NOV 30 1998
510(k) Summary
August 7, 1998
General Information
- Luther Medical Products, Inc. Applicant: 14332 Chambers Road Tustin, CA 92780-6912 Phone: (714) 544-3002 Fax: (714) 544-7273
- Kathleen Roberts Contact: (714) 544-3002, ext. 216
| Common Name: | Catheter Introducer |
|---|---|
| Trade Name: | Blunt T-Peel Plastic Sheath Introducer |
| Classification Name: | Catheter Introducer |
Predicate Devices
Luther Medical Products, Inc. T-Peel Introducer K924562
Bio-Plexus, Inc. Punctur-Guard® Blood Collection Needle K895024
Device Description
An over-the-needle peel-away plastic sheath catheter introducer which includes a blunting feature to blunt the tip of the needle after venous access.
Intended Use
Used to facilitate placement of an intravascular catheter through the skin into a vein and when used according to the Directions For Use, may reduce the risk of an accidental needlestick.
1
Comparison to Predicate Devices
Substantially equivalent to the T-Peel introducer with the addition of a needlestick protection feature that is comparable in safety and effectiveness to a similar feature in the Punctur-Guard® Blood Collection Needle.
Tests
The T-Peel Plastic Sheath Introducer has been on the market for several years and was previously tested and qualified. There are no design, dimensional or material changes to the device. Therefore no testing of the catheter introduction features are necessary.
The additional needlestick protection feature of the Blunt T-Peel Plastic Sheath Catheter Introducer has been evaluated according to a documented test protocol. All test results were satisfactory and met the protocol's requirements. The activation force was within specified limits. The puncture force with the shielded needle exceeded that with the unshielded needle in all cases. The force to override the needle shielding feature exceeds the minimum requirements.
2
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 eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration Rockville MD 20857
NOV 30 1998
Ms. Kathleen Roberts Regulatory Affairs Manager Luther Medical Products, Inc. 14332 Chambers Road Tustin, CA 92780-6912
Re : K982797 Blunt T-Peel Plastic Sheath Introducer Trade Name: Regulatory Class: II Product Code: DYB Dated: October 22, 1998 Received: October 23, 1998
Dear Ms. Roberts:
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 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 You may, therefore, market the device, subject to the Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices
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Page 2 - Ms. Kathleen Roberts
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 our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) Additionally, for questions on the promotion and advertising 594-4586. of your device, please contact the Office of Compliance at (301) 594-Also, please note the regulation entitled, "Misbranding by 4639. reference to premarket notification" (21CFR 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 "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K982797 510(k) Number:
Device Name:
Blunt T-Peel Plastic Sheath Introducer
Indications For Use:
The Blunt T-Peel Plastic Sheath Introducer is used to facilitate placement of a peripherally inserted intravenous catheter through the skin into a vein and when used according to the Directions For Use, may reduce the risk of an accidental needlestick.
A.D. Grant for T.J. Callahan
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K982797
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ V (Per 21 CFR 801.109)
OR
Over-The-Counter Use_