(231 days)
The Dynarex Intermittent Catheter is intended for use in male, female, and pediatric patients (children, adolescents and transitional adolescents) requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a natural urine flow or for those who have a significant volume of residual urine following a natural bladder-voiding episode. The catheter should not be retained in the human body for more than 24 hours.
The Intermittent Catheter consists of a flexible PVC tube. One end of the tube has two holes (eyelets) punched into the tube. These eyelets allow urine to enter the tube and be drained from the bladder. A piece of PVC connector (drain funnel) is attached to the opposite end of the PVC tube.
Here's a breakdown of the acceptance criteria and study information for the Dynarex Intermittent Catheter, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Characteristic | Predicate Device Performance (Self Cath, K100878) | Dynarex Intermittent Catheter Performance | Basis for Acceptance |
|---|---|---|---|
| Indications for Use | Bladder drainage | Substantially Equivalent | Comparison to Predicate (explicitly stated "Substantially Equivalent") |
| Target Population | Male, Female & Pediatric (Neonates, infants, children, adolescents, and transitional adolescents) | Male, Female & Pediatric (children, adolescents, and transitional adolescents) | Comparison to Predicate (slight difference in pediatric age range, but deemed substantially equivalent for adult and core pediatric use cases) |
| Materials | PVC | PVC | Material equivalence to predicate |
| Biocompatibility | ISO 10993 Part 5 & 10 (Cytotoxicity, Skin Irritation & Sensitization) | ISO 10993 Part 5 & 10 (Cytotoxicity, Skin Irritation & Sensitization) | Testing to recognized international standards (ISO 10993), matching predicate |
| Physical Testing | ASTM 10555 (Force to Break), ASTM F-623 (Flow Rate) | ASTM 10555 (Force to Break), ASTM F-623 (Flow Rate) | Testing to recognized ASTM standards, matching predicate |
| Anatomical sites | Urethral | Urethral | Urethral usage equivalence to predicate |
| Safety and Effectiveness | Deemed safe and effective (as per K100878 clearance) | Deemed safe and effective (as per Risk Analysis Report WL-E-19-12A) | Risk analysis (WL-E-19-12A, dated August 31, 2009) to demonstrate equivalence to the predicate's safety and effectiveness profile. |
Important Note: The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to the predicate device (Self Catheter, K100878). This is a common pathway for Class II devices where the FDA has not established specific performance standards or special controls. The "study that proves the device meets the acceptance criteria" is largely the comparison to the predicate device through the described technological characteristics, biocompatibility, and physical testing.
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: Not explicitly stated as "test set" in the context of a clinical performance study with human subjects. The evaluation conducted involved material characterization (biocompatibility) and physical testing. For these types of tests, specific sample sizes are determined by the test standards (e.g., ISO 10993, ASTM 10555, ASTM F-623), but the exact number of units tested is not provided in this summary.
- Data Provenance: Not applicable in the context of clinical data. The data provenance for the physical and biocompatibility testing would be from the manufacturer's own testing laboratories or contracted labs. These are typically controlled laboratory environments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. This 510(k) relies on demonstrating substantial equivalence through material properties, physical performance, and biocompatibility, not on a diagnostic accuracy study requiring expert consensus on a test set.
4. Adjudication Method for the Test Set
- Not Applicable. As there is no diagnostic accuracy study with a "test set" of cases, no adjudication method is relevant here.
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. This submission is for an intermittent medical catheter, not an AI-powered diagnostic device. Therefore, an MRMC study is not relevant or performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This device is hardware (a catheter), not a software algorithm.
7. The Type of Ground Truth Used
- Established Standards and Predicate Device Performance: The "ground truth" for this submission comes from:
- Recognized International Standards: ISO 10993 (for biocompatibility) and ASTM (for physical testing like force to break and flow rate). Meeting these standards against defined criteria serves as the ground truth for these aspects.
- Predicate Device Characteristics: The performance and characteristics of the legally marketed predicate device (Self Catheter, K100878) serve as the benchmark or "ground truth" against which the new device is compared for substantial equivalence. For instance, if the predicate device is known to have a certain flow rate range, the new device must fall within that acceptable range.
8. The Sample Size for the Training Set
- Not Applicable. This is not a machine learning or AI device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. This is not a machine learning or AI device.
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K103d86
510(K) SUMMARY (as required by 807.92(c))
Submitter of 510(k):
Dynarex Corporation 10 Glenshaw Street · · · Orangeburg, NY 10972 USA Phone: (845) 365-8200 Fax: (845) 365-8201
Contact Person:
Date of Summary:
September 23, 2010
Daniel Consaga
Trade/Proprietary Name:
Dynarex Intermittent Catheter
Urological Catheter and Accessories
Classification Name:
Product Code:
EZD
Intended Use:
The Dynarex Intermittent Catheter is intended for use in male, female, and pediatric patients (children, adolescents and transitional adolescents) requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a natural urine flow or for those who have a significant volume of residual urine following a natural bladdervoiding episode. The catheter should not be retained in the human body for more than 24 hours.
Device Description:
The Intermittent Catheter consists of a flexible PVC tube. One end of the tube has two holes (eyelets) punched into the tube. These eyelets allow urine to enter the tube and be drained from the bladder. A piece of PVC connector (drain funnel) is attached to the opposite end of the PVC tube.
Predicate Device:
Self Catheter, 510(k) Number K100878, manufactured by Holtedam 1, 3050 Humlebaek, Denmark
Substantial Equivalence:
The Dynarex Intermittent Catheter provides effective bladder drainage, and its function and performance are similar to the predicate device, Self Catheter, K100878, cleared on May 26, 2010, as presented in this 510(k)
Safety and Effectiveness of the device:
This device is as safe and effective as the predicate device cited above. This is better expressed in the Risk Analysis Report WL-E-19-12A, dated August 31, 2009.
1
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K.103086
510(K) SUMMARY (as required by 807.92(c))
....
Summary comparing technological characteristics with other predicate device: Dynarex Intermittent Catheter is similar in terms of intended use and technological characteristics to predicate devices. The device is substantially equivalent with respect to indications for use and other physical characteristics to predicate devices in terms of section 510(k) substantial equivalency.
Please find below a tabulated comparison supporting that this device is substantially equivalent to the predicate device in commercial distribution.
| TECHNOLOGICALCHARACTERISTICS | Self Cath CatheterK100878 | Dynarex Intermittent Catheter |
|---|---|---|
| Indications for use | Bladder drainage | Substantially Equivalent |
| Target Population | Male, Female & Pediatric(Neonates, infants, children,adolescents, and transitionaladolescents) | Male, Female & Pediatric(children, adolescents, andtransitional adolescents) |
| Materials | PVC | PVC |
| Biocompatibility | ISO 10993 Part 5 & 10Cytotoxicity, Skin Irritation &Sensitization | ISO 10993 Part 5 & 10Cytotoxicity, Skin Irritation &Sensitization |
| Physical Testing | ASTM 10555, Force to Break,ASTM F-623, Flow Rate | ASTM 10555, Force to Break,ASTM F-623, Flow Rate |
| Anatomical sites | Urethral | Urethral |
Performance Summary:
FDA has not established special controls or performance standards for this device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Daniel Consaga Quality Engineer, Regulatory Affairs Dynarex Corporation 10 Glenshaw Street ORANGEBURG NY 10962
JUN - 7 2011
Re: K103086
Trade/Device Name: Dynarex Intermittent Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: June 2, 2011 Received: June 3, 2011
Dear Mr. Consaga:
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 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 Division of Small Manufacturers, International 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Herbert Lemmer MD
lerbert 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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K.103086
Indications for Us
510(k) Number (if known): K103086
Device Name: Dynarex Intermittent Catheter
Indications for Use:
The Dynarex Intermittent Catheter is intended for use in male, female, and pediatric patients (children, adolescents and transitional adolescents) and
bladder drainage as determined by their physicial adolescents) requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a natural urine flow or for those in indicated for
significant volume of residual urine fow or for those who have a significant volume of residual urine following a natural bladder-voiding episode.
The catheter should not be retained in the business in the episode. The cather should not be retained in the following a natural bladder-voiding episode.
The catheter should not be retained in the human body for more than 24 hours.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Heuln Rem
n Sign-C
§ 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.