(38 days)
The Avail Sterile Water Filled Syringe is intended to be used to provide a sterile liquid for catheter inflation after insertion.
A sterile, water filled, single patient use syringe designed for catheter inflation only. Not for injection. The syringes are bulk packaged for sale to customers for inclusion in urological kits. The syringes are not marketed or sold as separate devices from urological kits. The intended use of the device is to provide a sterile liquid for Foley catheter inflation after insertion. The syringe cap is removed, the syringe luer tip connects directly to the catheter valve. The sterile water is expressed to inflate the catheter. The syringe is disconnected and discarded after use.
The provided submission, K112209, is for a Sterile, Water Filled Syringe (Pre-filled Catheter Inflation Syringe) by Avail Medical Products Inc. This device is not a software/AI device, but rather a medical device intended for catheter inflation. Therefore, most of the requested information regarding acceptance criteria, study details, ground truth, expert involvement, and AI-related metrics (like MRMC or standalone performance improvement) are not applicable to this type of submission.
Here's a breakdown of the relevant information from the document, acknowledging the limitations for a non-AI product:
1. A table of acceptance criteria and the reported device performance:
Since this is a non-AI medical device, the "acceptance criteria" are related to its physical and functional characteristics, and substantial equivalence to a predicate device, rather than diagnostic performance metrics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Composition | Utilizes polypropylene materials with medical grade, butyl rubber plunger tips and caps. (This matches the predicate device). |
| Sterilization Method | Terminally gamma sterilized. (This matches the predicate device). |
| Packaging | Bulk packaged for inclusion in customer urological kits. (This matches the predicate device). |
| Intended Use | To provide a sterile liquid for Foley catheter inflation after insertion. (This matches the predicate device and is the intended functionality). |
| Non-Clinical Testing | Acceptable results were obtained for standards testing, biocompatibility, and performance testing, demonstrating substantial equivalence to the predicate device. Specific numerical acceptance criteria or performance values are not detailed in the summary provided, but the conclusion states "acceptable results". |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not applicable as there was no "test set" in the context of an AI study. The "testing" referred to in the document is non-clinical performance and materials testing, not data-driven evaluation with a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as there was no "test set" and no ground truth established by experts in the context of an AI algorithm's performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as there was no "test set" requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study was not done. This is a non-AI medical device; such a study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone performance study in the context of an AI algorithm was not done. This is a non-AI medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
This information is not applicable as there was no "ground truth" in the context of evaluating an AI algorithm's performance. The "ground truth" for this device's functionality would be that it effectively and safely inflates catheters as intended, confirmed through engineering and biocompatibility testing.
8. The sample size for the training set:
This information is not applicable as there was no "training set" for an AI algorithm.
9. How the ground truth for the training set was established:
This information is not applicable as there was no "training set" for an AI algorithm.
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AVAIL MEDICAL PRODUCTS, INC., Premarket Notification - Special 510(k), Pre-filled Catheter Inflation Syringe K112209
SEP - 8 2011
LEX Medical
5950 Nancy Ridge Dr Suite 500 San Diego, CA 92121 858-457-1988 Main 858-558-7264 Fax www.flextronics.com
ATTACHMENT 3
SECTION 5:
510(K) Number; K112209
510(K) SUMMARY
| Requirement | Information |
|---|---|
| 510(K) Owner | Avail Medical Products Inc. |
| Address | 5950 Nancy Ridge Road, Ste.500 |
| San Diego | |
| CA 92121 | |
| USA | |
| Telephone # | 858-457-1988 |
| Fax # | 858-558-7264 |
| Contact Person | Steven A.Howell |
| Summary Preparation Date | August 10, 2011 |
| Proprietary Name | Sterile, Water Filled Syringe |
| Common Name | Pre-filled Catheter Inflation Syringe |
| Classification Name | Urological Catheter & Accessories |
| (21 CFR876.5130) Product Code KNY | |
| Legally marketed predicate device | Pre Filled Catheter Inflation Syringe (K90121) |
| Device Description | A sterile, water filled, single patient use syringe |
| designed for catheter inflation only. Not for | |
| injection. The syringes are bulk packaged for sale | |
| to customers for inclusion in urological kits. The | |
| syringes are not marketed or sold as separate | |
| devices from urological kits. The intended use of | |
| the device is to provide a sterile liquid for Foley | |
| catheter inflation after insertion. The syringe cap is | |
| removed, the syringe luer tip connects directly to | |
| the catheter valve. The sterile water is expressed | |
| to inflate the catheter. The syringe is disconnected | |
| and discarded after use. | |
| Intended Use of the Device | Pre-filled catheter inflation syringe for catheter |
| balloon inflation. The device is substantially | |
| equivalent to the predicate device. |
Page 1 of 2
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AVAIL MEDICAL PRODUCTS, INC., Premarket Notification - Special 510(k), Pre-filled Catheter Inflation Syringe K112209 Jose 2 12
АТТАСНМЕNT 3
| Requirement | Information |
|---|---|
| Technological Characteristics ofthe device compared to thepredicate device | The new device is substantially equivalent to thepredicate device. The new device has the sametechnological characteristics as the predicatedevice. Both devices utilize polypropylenematerials of construction with medical grade, butylrubber plunger tips and caps. Both devices areterminally gamma sterilized and bulk packaged forinclusion in customers urological kits. |
| Assessment of Non Clinical Testsused to support substantialequivalence | Sections 2 (standards testing), 15(biocompatibility) and 19 (performance testing) ofthis 510(k) submission identify the non clinical testsand results used to support substantial equivalenceto the predicate device |
| Assessment of Clinical Tests usedto support substantial equivalence | Not Applicable. No Clinical tests were conducted |
| Conclusion of tests used tosupport substantial equivalence tothe predicate device | A comparison of the acceptable results of thetesting completed on the new device and theresults of testing of the predicate device support aclaim of substantial equivalence between the newdevice and the predicate device |
. Page 2 of 2
Page 29 of 48
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings and tail feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Steven A. Howell Senior Director - Quality Assurance Avail Medical Products Inc. 5950 Nancy Ridge Road. Suite 500 SAN DIEGO CA 92121
- 8 2011 ్లో గ్రామం
Re: K112209
Trade/Device Name: Avail Sterile Water Filled Syringe Regulation Number: 21 CFR$ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KNY Dated: August 17, 2011 Received: August 19, 2011
Dear Mr. Howell:
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 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 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
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adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the au vitae ovents) (21 CFR 800); good and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rr you desire spochlo advice 10. your le ntersOffices/CDRH/CDRHOffices/ucm11.5809.htm for go to mep. 11 with wilder and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regalition interesarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Tou may obtain biller generational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert Lemun MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and · Radiological Health.
Enclosure
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ATTACHMENT 2 (continued)
SECTION 4:
INDICATIONS FOR USE
K112209 510(k) Number:
Avail Sterile Water Filled Syringe Device Name:
Indications For Use:
The Avail Sterile Water Filled Syringe is intended to be used to provide a sterile liquid for catheter inflation after insertion.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Over-the-Counter Use ______ (Per 21 CFR 801.109) Prescription Use _____________________________________________________________________________________________________________________________________________________________ or
For Professional Use Only (Medical Health Provider) _
Alh. Rogers
(Division Sign-Off) for H. Lehner
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number. K112209
CONFIDENTIAL
Page 27 of 48
§ 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.