(84 days)
Not Found
No
The 510(k) summary describes a simple, pre-filled syringe for catheter inflation and makes no mention of AI or ML technology.
No
The device provides sterile water for catheter inflation, which is a supportive rather than a direct therapeutic function. Therapeutic devices typically involve treating or diagnosing a medical condition.
No
Explanation: The device is intended for catheter inflation, which is a procedural function, not diagnosis. It does not gather information about a patient's health condition.
No
The device description clearly states it is a "sterile, single patient use, disposable device" and a "pre-filled syringe," indicating it is a physical hardware device, 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 provide sterile water for catheter inflation after insertion." This is a direct medical intervention/procedure, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description focuses on the physical characteristics and function of a syringe for inflation, not on analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of diagnostic purposes, measuring biomarkers, or providing information for diagnosis.
The device is a medical device used for a procedural purpose (catheter inflation), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Avail Sterile, Latex Free, Water Filled Syringe is intended to be used to provide a sterile liquid for catheter inflation after insertion.
Product codes (comma separated list FDA assigned to the subject device)
KNY
Device Description
The Avail Sterile, Latex Free, Water Filled Syringe is a sterile, single patient use, disposable device that is substantially equivalent to the predicate device and other pre-filled syringes. The device is designed for catheter inflation only and is intended for single patient use as was the predicate device.
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)
Not Found
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.
Horizon Prefilled Syringe For Inflation Of Foley Catheter, K952414
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
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
A VAIL MEDICAL PRODUCTS, INC., Premarket Notification - Special 510(k), Pre-filled Catheter Inflation Syringe
SECTION 5:
510(k) Summary
APR ] 5 2009
Submitter: Avall Medical Products, Inc.
1900 Camegie Avenue
Santa Ana, CA 92705
Contact: Kristen Drake
214-580-7039
Name of Device: Avail Sterile, Latex Free, Water Filled Syringe
Predicate Device: Horizon Prefilled Syringe For Inflation Of Foley Catheter, K952414
Description of the New Device: The Avail Sterile, Latex Free, Water Filled Syringe is a sterile, single patient use, disposable device that is substantially equivalent to the predicate device and other pre-filled syringes. The device is designed for catheter inflation only and is intended for single patient use as was the predicate device.
INTENDED USE OF THE NEW DEVICE: The Avail Sterile, Latex Free, Water Filled Syringe, is intended to be used to provide a sterile liquid for catheter inflation after insertion.
Comparison of the Technological Features of the New [Modified] Device and Predicate Devices: The device and the lawfully marketed predicate device contain similar materials of construction. Features of the device are comparable to those of the predicate device.
Signed,
Kristen Drake
Kristen Drake MA, CCRA, PA Regulatory Affairs Manager Avail Medical Products, Inc.
CONFIDENTIAL
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patricia A. Goeree Regulatory Specialist Avail Medical Products, Inc. 1900 Carnegie Avenue SANTA ANA CA 92705
APR 1 5 2009
Re: K090121 Trade/Device Name: Pre-Filled Catheter Inflation Syringe Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KNY Dated: March 13, 2009 Received: March 16, 2009
Dear Ms. Goeree:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/indr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
[signature]
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
AVAIL MEDICAL PRODUCTS, INC., Premarket Notification - Special 510(k), Pre-filled Catheter Inflation Syringe
Attachment 1
SECTION 4: INDICATIONS FOR USE
510(k) Number: K090121
Device Name: Sterile, Latex Free, Water Filled Syringe
Indications For Use:
The Avail Sterile, Latex Free, Water Filled Syringe is intended to be used to provide sterile water for catheter inflation after insertion.
Prescription Use X (Part 21 CFR 801 Subpart D) and/or
Over-the-Counter Use (Part 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulut Hemm
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
CONFIDENTIAL
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