(182 days)
Not Found
Not Found
No
The summary describes a standard medical catheter and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as image processing and performance studies typically associated with AI/ML devices.
Yes
The device is used for "selected intravenous therapies," which implies the administration of substances for treatment, thus qualifying it as a therapeutic device.
No
The device, a Per-Q-Cath® Midline Catheter, is indicated for peripheral access for intravenous therapies and blood sampling, which are functions related to treatment and collection, not diagnosis. It does not analyze data or provide diagnostic information.
No
The device description clearly states it is a physical catheter made of silicone or polyurethane, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as providing "peripheral access to the peripheral venous system for selected intravenous therapies and blood sampling." This is a description of a device used in vivo (within the body) for delivering substances and collecting samples.
- Device Description: The device is described as a "silicone or polyurethane open-ended catheter." This is a physical device inserted into the body.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such function.
Therefore, the Per-Q-Cath® Midline Catheter is a medical device used for patient care in vivo, not an IVD.
N/A
Intended Use / Indications for Use
For long term midline venous catheterization of selected intravenous infusates ox blood therapy. A midline catheter placement is contraindicated for patients requiring solutions with final glucose concentrations above 10 percent and solutions with protein concentrations above 5 percent and patients requiring continuous infusion of vesicants.
Per-Q-Cath® Midline Catheters are indicated for short or long term peripheral access to the peripheral venous system for selected intravenous therapies and blood sampling. A midline catheter is contraindicated for patients requiring solutions with final glucose concentrations above 10 percent and solutions with protein concentrations above 5 percent and patients requiring continuous infusion of vesicants.
Product codes
FOZ
Device Description
Per-Q-Cath midlines are silicone or polyurethane open-ended catheters in single or dual lumen configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral venous system
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
No performance testing was done. A comparison of catheter tip trimming instructions from various competitors and a literature bibligraphy were sent to FDA to support the change in tip trimming instructions.
Key Metrics
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
KG71991
510 (x) BUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION K971991
NOV - 7 1997
Submitter Information: 人。
D.H.J. FILLD Hosonning ID our Jos
Bard Access Systems, Inc. (Division of C.R. Submitter Name: Bard, Inc.) 5425 W. Amelia Earhart Drive Address : Salt Lake City, UT 84116 (801) 595-0700 ex 4982 Telephone Number: (801) 595 4979 Fax Number: Jane Ann Martin Contact Person: 5 November 1997 Date of Preparation:
Device Name: B.
Per-Q-Cath® Midline Catheters Common/Usual Name:
Classification Name: Long-term Intravascular catheter (LJS)
Predicate Device Name: c. Per-Q-Cath® Midline catheters Trade Name:
D. Device Description:
Per-Q-Cath midlines are silicone or polyurethane open-ended catheters in single or dual lumen configurations.
E . Intended Use:
For long term midline venous catheterization of selected intravenous infusates ox blood therapy. A midline catheter placement is contraindicated for patients requiring solutions with final glucose concentrations above 10 percent and solutions with protein concentrations above 5 percent and patients requiring continuous infusion of vesicants.
P. Technological Characteristics Summary
This 510(k) does not involve any technological characteristic changes. This submission was to change the tip trimming instructions in the Instructions For Use only. No changes were made to the catheters.
Performance Data (if applicable) G.
No performance testing was done. À comparison of catheter tip trimming instructions from various competitors and a literature bibligraphy were sent to FDA to support the change in tip trimming instructions.
1
Image /page/1/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines connecting them. The text "U.S.A" is located at the top right of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 7 199
Ms. Jane Ann Martin Requlatory Affairs Manager Bard Access Systems, Incorporated 5425 West Amelia Earnhart Drive Salt Lake City, Utah 84116
Re : K971991 Gesco Per-O-Cath® Midline Catheters Trade Name: Regulatory Class: II Product Code: FOZ Dated: August 7, 1997 Received: August 11, 1997
Dear Ms. Martin:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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
2
Page 2 - Ms. Martin
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or __ requlations.
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) 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 regulation 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 "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
y A. Ulatowski Timot Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
- Enclosure
3
INDICATION(S) STATEMENT* K971991
I state in my capacity as Regulatory Affairs Manager of Bard Access Systems, that this I state in my capacity as regulatory interior . Per-Q-Cath® Midline Catheters, are indicated for the following:
Per-Q-Cath® Midline Catheters are indicated for short or long term peripheral access to the peripheral venous system for selected intravenous therapies and blood sampling. A midline catheter is contraindicated for patients requiring solutions with final glucose concentrations above 10 percent and solutions with protein concentrations above 5 percent and patients requiring continuous infusion of vesicants.
Amaster
Signature of 510(k) Submitter
Jane Ann Martin Printed Namc of Submitter
b 700 57
Datc
*Suggested language and format to meet the requirements of sections 513(i) of the Federal Food, Drug, and Cosmotic Act, as amended, and sections 807.92(a)(5) and 801.4 of the Code of Federal Regulations, Title 21.
Patricio Cucurella
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K971991
Prescription Use
(Per 21 CFR 801.109)