(86 days)
Not Found
No
The summary describes a physical medical device (catheter) and its materials, with no mention of software, algorithms, or AI/ML terms.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used for the therapeutic or diagnostic aspiration of fluid or air." Since one of its stated uses is therapeutic, it qualifies as a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used for "therapeutic or diagnostic aspiration."
No
The device description clearly states it is comprised of a physical catheter, needle, stopcock, valve, and syringe, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "therapeutic or diagnostic aspiration of fluid or air from the abdominal cavity." This describes a procedure performed directly on the patient's body to collect a sample or relieve pressure.
- Device Description: The device is a "catheter over the needle" designed for insertion into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. This device is used in vivo (inside the body) to collect the specimen.
The diagnostic aspect of this device refers to the purpose of collecting the fluid (for later analysis), not the device itself performing the diagnostic test. The analysis of the collected fluid would likely be performed using separate IVD devices.
N/A
Intended Use / Indications for Use
The paracentesis catheter is a device used for the therapeutic or diagnostic aspiration of fluid or air from the abdominal cavity.
Product codes (comma separated list FDA assigned to the subject device)
GCB
Device Description
The paracentesis "catheter over the needle" is comprised of a Radiopague Polyurethane Catheter over a needle with stopcock, self-sealing valve and 5 cc syringe attached.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity
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)
The biocompatibility tests performed were cytotoxicity, sensitization, irritation or intracutaneous reactivity, systemic toxicity (acute) and hemocompatibility as identified on the tests for each material. These materials have met the testing requirements and were found to be acceptable for the intended use.
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.
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
§ 878.4200 Introduction/drainage catheter and accessories.
(a)
Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
K974146
Allegian
JAN 2 8 1998
Allegiance Healthcare Corporation 500 Waukegan Road AcGaw Park, Illinois 60085-6787 47.473.1500 FAX: 847.785.2461
SMDA REQUIREMENTS XII.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS PARACENTESIS CATHETER
Manufacturer:
Allegiance Healthcare Corporation 400 East Foster Road Mannford, OK 74044
Regulatory Affairs Contact:
Sharon Robbins Allegiance Healthcare Corporation 1500 Waukegan Road MP-WM McGaw Park, IL 60085
Telephone:
Common Name:
Classification:
Description:
Predicate Device:
Date Summary Prepared: October, 1997
Paracentesis Catheter
(847) 785-3311
Class II per 21CFR § 878.4200, Needle, Catheter
Paracentesis Catheter device, K870704 owned by Allegiance Healthcare Corporation
The paracentesis "catheter over the needle" is comprised of a Radiopague Polyurethane Catheter over a needle with stopcock, self-sealing valve and 5 cc syringe attached.
14
1
XII. SMDA REQUIREMENTS (continued)
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS PARACENTESIS CATHETER
Intended Use: The paracentesis catheter is a device used for the therapeutic or diagnostic aspiration of fluid or air from the abdominal cavity. Substantial
Equivalence:
The proposed Allegiance Paracentesis Catheter is substantially equivalent to the currently marketed Allegiance Paracentesis Catheter in that:
- intended use is the same
- performance attributes are the same
All materials used in the fabrication of this paracentesis Summary of testing: device were evaluated through biological qualification safety tests. The biocompatibility tests performed were cytotoxicity, sensitization, irritation or intracutaneous reactivity, systemic toxicity (acute) and hemocompatibility as identified on the tests for each material. These materials have met the testing requirements and were found to be acceptable for the intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the circumference.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 28 1998
Ms. Sharon Robbins 'Manager of Requlatory Affairs Alleqiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787
Re : K974146 Paracentesis Catheter Device Trade Name: Requlatory Class: II Product Code: GCB Dated: October 30, 1997 Received: November 3, 1997
Dear Ms. Robbins:
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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 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.
3
Page 2 - Ms. Sharon Robbins
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) 594-4595. 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,
Celia M. Witten, Ph.D., M.D.
Director
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Allegiance
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461
Indications for Use
510(k) Number (if known):
Device Name:
.
Paracentesis Catheter
Indications For Use:
The paracentesis catheter is a device used for the therapeutic or diagnostic aspiration of fluid or air from the abdominal cavity.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | -- |
or
| Over-The Counter Use | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | 2974146 |