(28 days)
Not Found
No
The device description and performance studies focus on the physical properties, sterility, and functionality of a pre-filled syringe, with no mention of AI or ML.
No
The device is used to inflate a Foley catheter balloon for mechanical retention, not to directly treat a disease or condition.
No
Explanation: The device is intended for inflating a Foley catheter balloon, which is a functional purpose, not for diagnosing any medical condition.
No
The device description clearly outlines a physical syringe prefilled with water, made of polypropylene and rubber, and sterilized via gamma irradiation. It is a hardware device.
Based on the provided information, the AquaFlate Pre-filled Sterile Water Syringe is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly stated as "inflating a Foley catheter balloon." This is a mechanical function related to a medical device (the catheter), not a diagnostic test performed on a sample from the human body.
- Device Description: The device is a syringe prefilled with sterile water. It's used to physically inflate a balloon. There is no mention of it being used to analyze or test any biological sample.
- Lack of Diagnostic Elements: IVD devices are designed to perform tests on samples like blood, urine, tissue, etc., to provide information for diagnosis, monitoring, or screening. This device does none of that.
The device is a medical device used in conjunction with a Foley catheter, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AquaFlate Pre-filled Sterile Water Syringe is intended to be used for inflating a Foley catheter balloon.
Product codes
EZL
Device Description
The proposed device, AquaFlate Pre-Filled Sterile Water Syringe 10mL (REF 250-400), is a 10mL syringe prefilled with USP purified water and sterilized via gamma irradiation. The syringe consists of a polypropylene barrel and plunger and latex free rubber for both the plunger gasket and syringe tip cap.
The AquaFlate Pre-Filled Water Syringe 10mL is intended for inflating an indwelling. urethral Foley catheter balloon. In accordance with CDC Guidelines, healthcare facility protocols, and the Foley catheter manufacturer's instructions for use, prior to catheterization, the syringe cap of the AquaFlate Pre-Filled Sterile Water Syringe 10mL is removed and the luer tip of the syringe is connected to the inflation port of the catheter. Once the catheter is inserted into the bladder, the entire contents of the syringe are dispensed to inflate the catheter balloon to ensure the catheter does not slide out. After balloon inflation, the syringe is disconnected from the catheter inflation port and discarded.
The AquaFlate Pre-Filled Sterile Water Syringe 10mL is not intended for injection and is for single use only.
The shelf life of the AquaFlate Pre-Filled Sterile Water Syringe 10mL is one (1) year.
HR Pharmaceuticals does not intend to market this device with accessories or as part of a system.
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
Healthcare Facility
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
Bench Testing:
- Small-bore connector testing ISO 80369-7:2016. Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications [FR Recognition No. 5-115]
- Manual, single-use syringe testing - ISO 7886-1:2017, Sterile hypodermic syringes for single use - Part 1: Syringes for manual use [FR Recognition No. 6-404]
- Sterility USP 42 Chapter Sterility Tests [FR Recognition No. 14-532]
Biocompatibility Testing:
Conducted in accordance with FDA Final Guidance "Use of International Standard ISO-10993, 'Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process, " June 16, 2016, and International Standard ISO 10993-1:2009 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. Yielded acceptable results for:
- Cytotoxicity ANSI/AAMI/ISO 10993-5:2009 (R) 2014 Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity [FR Recognition No. 2-245]
- Irritation ANSI/AAMI/ISO 10993-10:2013—Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization [FR Recognition No. 2-174]
- Sensitization - ANSI/AAMI/ISO 10993-10:2013—Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization [FR Recognition No. 2-174]
Sterilization:
Validated using gamma irradiation at a minimum dose of 25kGy and a maximum dose of 40kGy to achieve a Sterility Assurance Level of 10-6 in accordance with recognized standards (ANSI/AAMI/ISO 11137-1, -2, -3; ANSI/AAMI/ISO 11737-1, -2; AAMI TIR 17-2008; ANSI/AAMI/ISO TIR13004).
Packaging Validation and Shelf Life:
Underwent packaging validation testing and accelerated aging testing per standards to support a one-year shelf life.
- ISTA Procedure 3A (2018) Series. General Simulation Performance Test Procedure Packaged-Products for Parcel Delivery System Shipment 150lb or less.
- ASTM D4169-16. Performance Testing of Shipping Containers and Systems [FR Recognition No. 14-499]
- ASTM F1980-16. Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices [FR Recognition No. 14-497]
Key results: All necessary testing has been performed on the AquaFlate Pre-Filled Sterile Water Syringe 10mL to support the safety and effectiveness of the device per its intended use. Additionally, the performance testing concluded that the subject device is substantially equivalent to the legally marketed predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font in blue.
March 31, 2020
HR Pharmaceuticals, Inc. % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
Re: K200556
Trade/Device Name: AquaFlate Pre-Filled Sterile Water Syringe 10mL Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: March 2, 2020 Received: March 3, 2020
Dear Prithul Bom:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica K. Nguyen, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K200556
Device Name
AquaFlate Pre-filled Sterile Water Syringe 10 mL
Indications for Use (Describe)
The AquaFlate Pre-filled Sterile Water Syringe is intended to be used for inflating a Foley catheter balloon.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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K200556 Page 1 of 6
510(k) SUMMARY 5-1
5.0 510(k) SUMMARY
510(k) SUMMARY for AquaFlate Pre-Filled Sterile Water Syringe 10mL
I. SUBMITTER:
HR Pharmaceuticals, Inc. 2600 Eastern Boulevard, Suite 201 York, PA 17402
Telephone Number:717-252-1110 x104 Fax Number:717-685-2590
Contact Person: Colby Wiesman Date Prepared: November 26, 2019
II. DEVICE:
Name of Device: AquaFlate Pre-Filled Sterile Water Syringe 10mL Model Number: 250-400 Common or Usual Name: Catheter, Retention type, balloon Classification Description: Urological catheter and accessories (21 CFR 876.5130) Regulatory Class: II Product Code: EZL Review Panel: Gastroenterology/Urology
III. PREDICATE DEVICES:
AMSINO INTERNATIONAL, AMSure® Prefilled Syringe for Balloon Inflation with Sterile Water, K181814
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION:
The proposed device, AquaFlate Pre-Filled Sterile Water Syringe 10mL (REF 250-400), is a 10mL syringe prefilled with USP purified water and sterilized via gamma irradiation. The syringe consists of a polypropylene barrel and plunger and latex free rubber for both the plunger gasket and syringe tip cap.
The AquaFlate Pre-Filled Water Syringe 10mL is intended for inflating an indwelling. urethral Foley catheter balloon. In accordance with CDC Guidelines, healthcare facility protocols, and the Foley catheter manufacturer's instructions for use, prior to catheterization, the syringe cap of the AquaFlate Pre-Filled Sterile Water Syringe 10mL is
Image /page/3/Picture/17 description: The image shows the logo for H-R Pharmaceuticals, Inc. The logo is in blue and features the letters "H-R" in a stylized font. To the right of the letters is the text "Pharmaceuticals, Inc." The logo is simple and professional, and it is likely used on the company's website, marketing materials, and products.
4
removed and the luer tip of the syringe is connected to the inflation port of the catheter. Once the catheter is inserted into the bladder, the entire contents of the syringe are dispensed to inflate the catheter balloon to ensure the catheter does not slide out. A fter balloon inflation, the syringe is disconnected from the catheter inflation port and discarded.
The AquaFlate Pre-Filled Sterile Water Syringe 10mL is not intended for injection and is for single use only.
The shelf life of the AquaFlate Pre-Filled Sterile Water Syringe 10mL is one (1) year.
HR Pharmaceuticals does not intend to market this device with accessories or as part of a system.
V. INDICATIONS FOR USE:
The AquaFlate Pre-Filled Sterile Water Syringe 10mL is intended to be used for inflating a Foley catheter balloon.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES:
The subject and predicate devices have the same technological principle whereby, the prefilled sterile water syringe is intended for inflating an indwelling, urethral Foley catheter balloon. Once the catheter is inserted into the bladder, the entire contents of the syringe are dispensed to inflate the catheter balloon to ensure the catheter does not slide out. After balloon inflation, the syringe is disconnected from the catheter inflation port and discarded. Additionally, the prefilled sterile water syringe is not intended for injection and is for single use only.
At a high level, the AquaFlate Pre-Filled Sterile Water Syringe 10mL and the predicate device are based on the following same elements:
- Same Intended Use
- Same Technological Characteristics ●
- Same Materials
- . Same Physical Characteristics
- Same Performance Specifications ●
- Packaged in the same quantity (10mL) ●
- o Provided sterile
- Biocompatible
The only identified difference between the subject and predicate devices is the shelf life. The AquaFlate Pre-Filled Sterile Water Syringe 10mL has a one-year shelf life whereby, AMSure® Prefilled Syringe for Balloon Inflation with Sterile Water has a three-year shelf life. While the AquaFlate Pre-Filled Sterile Water Syringe 10mL is currently undergoing 2 year and 3-year shelf life testing, the one-year established shelf life for the subject device is acceptable for the intended use as demonstrated by successful stability
Image /page/4/Picture/21 description: The image shows the logo for H-R Pharmaceuticals, Inc. The logo is in blue and features the letters "H" and "R" in a stylized font. To the right of the "R" is a symbol that looks like a water droplet inside of a flower. The words "Pharmaceuticals, Inc." are written in a smaller font to the right of the letters.
5
and performance testing. Therefore, the difference in shelf life between the subject and predicate devices does not raise new questions of safety or effectiveness.
A more detailed comparison of the predicate and subject devices is presented in the table below.
| | Proposed Device
AquaFlate Pre-Filled Sterile
Water Syringe 10mL | Predicate Device
AMSure Prefilled
Syringe for Balloon
Inflation with Sterile
Water
(K181814) | Comparison | |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|------|
| Manufacturer | HR Pharmaceuticals, Inc. | Amsino International, Inc. | N/A | |
| Device Classification
Name | Catheter, Retention Type,
Balloon | Catheter, Retention Type,
Balloon | Same | |
| Regulation Description | Urological catheter and
accessories | Urological catheter and
accessories | Same | |
| Review Panel | Gastroenterology/Urology | Gastroenterology/Urology | Same | |
| Product Code | EZL | EZL | Same | |
| Reg Number | 876.5130 | 876.5130 | Same | |
| Class | II | II | Same | |
| Indications for Use | The AquaFlate Pre-Filled Sterile
Water Syringe 10mL is intended
to be used for inflating a Foley
catheter balloon. | Prefilled Syringe for
Balloon Inflation with
Sterile Water is intended
to be used in inflating
foley catheter balloon. | Same | |
| Patient-contacting
material | Indirect patient contact of sterile
water used to inflate a catheter
balloon | Indirect patient contact of
sterile water used to
inflate a catheter balloon | Same | |
| Sizes | 10mL | 10cc and 30cc | Same
(10mL) | |
| Materials of
Main
Components | Barrel | Polypropylene | Polypropylene | Same |
| | Plunger | Polypropylene | Polypropylene | Same |
| | Plunger
Gasket | Isoprene (black synthetic rubber
that does not contain natural
rubber latex) | Black pharmaceutical
grade,
synthetic rubber (Latex
free) | Same |
| | Tip
Cover | Isoprene (black synthetic rubber
that does not contain natural
rubber latex) | Same as gasket | Same |
| | Solution | Purified water, USP | Purified water, USP | Same |
| Principle of Operation | | Manual | Manual | Same |
| Technical Performance | | Conforms with ISO7886-1,
ISO 80369-7 and USP 42
Chapter | Conforms with ISO7886-
1,
ISO 80369-7 and USP 40 | Same |
| Biocompatibility | | Meets ISO 10993-1:2009
requirements for irritation (ISO
10993-10), sensitization (ISO | Conforms with ISO
10993-5 and ISO 10993-
10 | Same |
| | Proposed Device
AquaFlate Pre-Filled Sterile
Water Syringe 10mL | Predicate Device
AMSure Prefilled
Syringe for Balloon
Inflation with Sterile
Water
(K181814) | Comparison | |
| | 10993-10), and cytotoxicity
(ISO 10993-5) | | | |
| Utility | Single Use | Single Use | Same | |
| Sterility (Method) | Sterile (Gamma Irradiation) | Sterile (Gamma Irradiation) | Same | |
| Environment of Use | Healthcare Facility | Healthcare Facility | Same | |
| Labeling | Prescription Use | Prescription Use | Same | |
| Shelf Life | 1 year | 3 years | Different | |
| Device Picture | Image: syringe | Image: syringes | N/A | |
Image /page/5/Picture/6 description: The image shows the logo for H-R Pharmaceuticals, Inc. The logo is blue and features the letters "H" and "R" in a stylized font. To the right of the "R" is a symbol that looks like a water droplet inside of a flower. The words "Pharmaceuticals, Inc." are written in a smaller font to the right of the "R".
6
*Values obtained from performance testing conducted per HR Pharmaceuticals' protocols.
VII. PERFORMANCE DATA
There are no FDA device-specific guidance documents, special controls document, and/or requirements in a device-specific regulation for prefilled sterile water syringes. Additionally, no performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for prefilled sterile water syringes. However, the following performance data were provided in support of the substantial equivalence determination.
Bench Testing
- Small-bore connector testing ISO 80369-7:2016. Small-bore connectors for ● liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications [FR Recognition No. 5-115]
- Manual, single-use syringe testing - ISO 7886-1:2017, Sterile hypodermic syringes for single use - Part 1: Syringes for manual use [FR Recognition No. 6-404]
- Sterility USP 42 Chapter Sterility Tests [FR Recognition No. 14-532] ●
Biocompatibility Testing
The biocompatibility evaluation for the AquaFlate Pre-Filled Sterile Water Syringe 10mL was conducted in accordance with the FDA Final Guidance "Use of International Standard ISO-10993, 'Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process, " June 16, 2016, and International Standard ISO 10993-1:2009 "Biological Evaluation of Medical Devices - Part 1: Evaluation and
Image /page/6/Picture/13 description: The image shows the logo for H-R Pharmaceuticals, Inc. The logo is in blue and features the letters "H" and "R" in a stylized font. To the right of the "R" is a symbol that looks like a water droplet inside of a circle. The words "Pharmaceuticals, Inc." are written in a smaller font to the right of the letters.
7
Testing Within a Risk Management Process," as recognized by FDA. The biocompatibility testing included the following and yielded acceptable results:
- Cytotoxicity ANSI/AAMI/ISO 10993-5:2009 (R) 2014 Biological Evaluation of ● Medical Devices Part 5: Tests for In Vitro Cytotoxicity [FR Recognition No. 2-245]
- Irritation ANSI/AAMI/ISO 10993-10:2013—Biological Evaluation of Medical . Devices-Part 10: Tests for Irritation and Skin Sensitization [FR Recognition No. 2-1741
- . Sensitization - ANSI/AAMI/ISO 10993-10:2013—Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization [FR Recognition No. 2-174]
The AquaFlate Pre-Filled Sterile Water Syringe 10mL falls into the category of limited (