(182 days)
Not Found
Not Found
No
The summary describes a physical catheter and does not mention any software, algorithms, or data processing related to AI/ML.
Yes
The device is indicated for "intravenous therapy," which is a form of medical treatment.
No
Explanation: The device is a catheter used for intravenous therapy and blood sampling, not for diagnosing medical conditions.
No
The device description clearly states it is a physical catheter made of silicone or polyurethane, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "peripheral access to the central venous system for intravenous therapy and blood sampling." This describes a device used in vivo (within the body) for delivering substances and collecting blood directly from the bloodstream.
- Device Description: The description of the device as "silicone or polyurethane open-ended catheters" further supports its use as an implanted or inserted medical device.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. The provided information does not mention any such use or analysis of specimens.
Therefore, the Per-Q-Cath PICC is a medical device used for direct access to the central venous system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For long term central venous catheterization for intravenous or blood therapy.
Per-Q-Cath PICCs are indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
Per-Q-Cath PICCs 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
Not Found
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)
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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Per-Q-Cath® PICCs
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 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
NUV UJ DI 10.41 NO. U11 F.U4
510 (x) SUPPORTY OF SAFETY AND EFFECTIVENESS INFORMATION K971990
ート アンバー レディー コーナー
.
NOV - 7 1997
- Submitter Information: A.
・・・・・・・・・・・・・
Bard Access Systems, Inc. (Division of C.R. Submitter Name: Bard, Inc.) 5425 W. Amelia Earhart Drive Address: Salt Lake City, UT 84116 Telephone Number: (801) 595 4979 Fax Number: Jane Ann Martin Contact Person: Date of Preparation: 5 November 1997
Device Name: B.
| Common/Usual Name: | Per-Q-Cath® PICCs (Peripherally Inserted Central Catheters) |
|---|---|
| -------------------- | ------------------------------------------------------------- |
Long-term Intravascular catheter (LJS) Classification Name:
C. Predicate Device Name:
Per-Q-Cath® PICCs (Peripherally Inserted Central Trade Name: Catheters
D. Device Dascription:
Per-Q-Cath PICCs are silicone or polyurethane open-ended catheters in single or dual lumen configurations.
B. Intended Use:
For long term central venous catheterization for intravenous or blood therapy .
י . 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.
હં. Performance Data (if applicable)
No performance teating 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.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jane Ann Martin ·Regulatory Affairs Manager Bard Access Systems, Incorporated 5425 West Amelia Earnhart Drive Salt Lake City, Utah 84116
K971990 Re : Gesco Per-O-Cath® Picc Catheters Trade Name: Requlatory Class: II Product Code: FOZ Dated: Auqust 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 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੋ 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 requlation (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 action. In addition, FDA 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
NOV - 7 1997
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;
Timothy A. Ulatowski 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* K971990
I state in my capacity as Regulatory Affairs Manager of Bard Access Systems, that this notification (510(k)) for the following devices, Per-Q-Cath® PICCs, are indicated for the following:
Per-Q-Cath PICCs are indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
Amertus
Signature of 510(k) Submitter
Jane Ann Martin Printed Name of Submitter
6 Nov 97
Date
*Suggested language and format to meet the requirements of sections 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and sections 807.92(a)(5) and 801.4 of the Code of Federal Regulations, Title 21.
Paharia Cucente
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use . (Per 21 CFR 801.109)