(13 days)
K#953811
Not Found
No
The summary describes a standard intravenous catheter kit and explicitly states that AI, DNN, or ML were not found in the description.
Yes
The device is used for the administration of fluids, medications, and/or nutritional therapy, which are common therapeutic interventions.
No
The device is described as an intravenous catheter used for fluid, medication, or nutritional therapy, which are therapeutic rather than diagnostic purposes.
No
The device description explicitly states it is an intravenous catheter, which is a physical hardware device. The summary does not mention any software component that constitutes the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for administering fluids, medications, and/or nutritional therapy directly into the central venous system. This is a therapeutic and delivery function, not a diagnostic one.
- Device Description: The device is described as intravenous catheters, which are used for accessing the bloodstream for delivery or withdrawal, not for performing tests on samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is designed for direct patient intervention and therapy delivery.
N/A
Intended Use / Indications for Use
The devices are intended for use when central venous catheterization or intravenous therapy for the administration of fluids, medications and/or nutritional therapy is prescribed. The use of the device for these indications is less than 30 days.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
Single or double lumen intravenous catheters. Devices will be assembled in a kit that includes components that are either legally marketed; exempt from premarket requirements; or "grandfathered".
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)
Non clinical (bench) testing was completed to support K#953811, and was included with this 510(k) submission
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.
K#953811
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
Keystone Medical PICC Catheters 510(k) Summary
JUN 2 7 2001
Attachment 1
510(K) SUMMARY
This summary of 510(k) -safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 5|0(k) number is:
Submitter's Identification: 1.
Tony Madison, President Keystone Medical 1338 Michael Way Lansdale, PA. 19446
Date Summary Prepared: May 29, 2001
2. Name of the Device:
Keystone Medical Peripherally Inserted Central Catheter (PICC)
3. Predicate Device Information:
These devices are substantially equivalent to devices currently marketed by Medical Components, Inc. Lansdale, PA under K#953811. Medical Components will continue to manufacture these devices.
4. Device Description:
Single or double lumen intravenous catheters. Devices will be assembled in a kit that includes components that are either legally marketed; exempt from premarket requirements; or "grandfathered".
5. Intended Use:
The devices are intended for use when central venous catheterization or intravenous therapy for the administration of fluids, medications and/or nutritional therapy is prescribed. The use of the device for these indications is less than 30 days.
6. Comparison to Predicate Devices:
The Keystone Medical Lumen Catheter is identical to the predicate.
The Keystone device will differ only in that the Keystone Medical name and logo will appear on the unit labels, box labels, and instructions for use. Keystone will also develop it's own sell sheets for these devices in the future.
1
ll 8660
Attachment 1
Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:
Non clinical (bench) testing was completed to support K#953811, and was included with this 510(k) submission
Discussion of Clinical Tests Performed: 8.
Clinical testing was not completed.
9. Conclusion
The Keystone Medical PICC catheters are safe and effective for their intended use.
2
Image /page/2/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 eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.
JUN 2 7 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Keystone Medical C/O Mr. Alan P. Schwartz Executive Vice President MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re : K011860 Trade/Device Name: Keystone Medical PICC Catheter Regulation Number: 880.5200 Requlatory Class: II Product Code: FOZ Dated: June 12, 2001 Received: June 14, 2001
Dear Mr. Schwartz:
We have reviewed your Section 510(k) notification of intent to we have reviewed 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 Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with 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 regulatory action. In addition, FDA may publish further announcements
3
Page 2 - Mr. Schwartz
concerning your device in the Federal Register. Please note: this response to your premarket notification submission does entb response or obligation you might have under sections 531 not arress and of the Act for devices under the Electronic chrough 312 or on 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 described in your sia equivalence of your device to a legally marketed predicate device results in a classification for your marketed predicate with your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in regaraciasmostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact che office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). J Other general information on your responsibilities under the Act may be Information on your color 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,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Keystone Medical PICC Catheter Indications for Use
Attachment 3
of イ Page
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: Keystone Medical PICC Catheters
Indications for Use:
The devices are intended for use when central venous catheterization or intravenous therapy for the administration of fluids, medications and/or nutritional therapy is prescribed. The use of the device for these indications is less than 30 days.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Petuna Cacciste
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 4011840 1510(k) Number -
(Optional Format 1-2-96)