(30 days)
This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.
- A patient with isolated pulmonary stenosis
- A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.
The COEfficient PTV Catheter is a coaxial over-the-wire catheter with a balloon near the distal tip. One lumen permits guidewire insertion to facilitate advancement of the catheter into the pulmonary valve while the other lumen is for balloon inflation and deflation. The balloon of the COEfficient model is made of a non-compliant polyethylene. The balloons are designed to inflate to a specific diameter at a given pressure. The change in diameter is minimal over the range of inflation pressures. The catheter body ends proximally in a bifurcated 'Y' connector with a guidewire port and a balloon extension. The balloon extension is marked with the product lot number and the balloon size. The outer body and inner body tubing is made of pebax. The area under the balloon is enhanced with either one or two radiopaque platinum image bands depending on the model. If marked with one image band, it is centered under the midpoint of the balloon. If it is marked with two image bands, they are located under the shoulders of the balloon. This catheter is of the same design and construction as the NuMED PTV catheters for which the 510(K) has been approved. The differences are lower profile, smaller shaft, and higher rated burst pressure.
Here's an analysis of the provided text regarding the NuMED COEfficient PTV Catheter, focusing on acceptance criteria and study information:
Based on the provided Summary of Safety and Effectiveness Data for the NuMED COEfficient PTV Catheter (K014124), the device's acceptance criteria and studies primarily revolve around demonstrating substantial equivalence to a predicate device and meeting biocompatibility and bench testing standards.
It's important to note that this document is a 510(k) summary, which typically focuses on demonstrating equivalence rather than an independent clinical study proving efficacy against specific quantitative clinical outcomes.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implicitly defined by the characteristics of the predicate device, the NuMED Z-MED PTV Catheter. The device performance is reported as meeting or being comparable to these characteristics, with specific improvements highlighted.
| Acceptance Criteria Category | Specific Criteria (from predicate/general standards) | Reported Device Performance (NuMED COEfficient PTV Catheter) |
|---|---|---|
| Indications for Use | PTV of pulmonary valve for isolated pulmonary stenosis or valvular pulmonary stenosis with minor congenital heart disease not requiring surgical intervention. | Meets: Same stated indications for use. |
| Biocompatibility | Compliance with Tripartite Biocompatibility Guidance for Medical Devices. | Meets: Materials are the same as previously approved PTA and PTV catheters, which were tested and found biocompatible. Results are on file at NuMED, Inc. |
| Bench Testing | Adherence to GMPs for performance (e.g., burst pressure, inflation diameter, shaft integrity). | Meets: All bench testing performed in accordance with GMPs. Results are on file at NuMED, Inc. |
| Device Design & Materials | Coaxial, over-the-wire catheter with non-compliant balloon, specific materials (Pebax, PES2, Platinum image bands). | Meets/Improved: Same fundamental design and construction (coaxial, non-compliant balloon, specified materials). |
| Physical Dimensions | Varies by model (e.g., Introducer, Shaft Size, Guidewire Size, Usable Length, Balloon Diameter/Length), as defined by predicate range. | Improved/Different: - Introducer: 4 Fr - 7 Fr (Lower Profile)- Shaft Size: 3.5 Fr (Smaller Shaft)- Guidewire Size: 0.018"- Usable Length: 75 cm- Balloon Diameter: 4 mm - 12 mm- Balloon Length: 2 cm - 4 cm |
| Rated Burst Pressure | Implicitly, a safe and effective burst pressure for intended use. | Improved: Higher rated burst pressure (stated qualitatively compared to predicate). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical "test set" in the traditional sense of a patient cohort. The support for the device largely comes from:
- Materials Biocompatibility Testing: The "test set" here would refer to the materials themselves. The document states the materials were tested, but does not specify the sample size of material samples or the specific tests performed (though it references the Tripartite Biocompatibility Guidance).
- Laboratory (Bench) Testing: The "test set" here refers to the device units subjected to various bench tests (e.g., burst pressure, dimensional accuracy). The document states "All bench testing was performed," but does not specify the sample size of devices tested for each parameter.
- Comparison to Predicate: The "test set" is effectively the design and performance specifications of the NuMED COEfficient PTV Catheter compared to the NuMED Z-MED PTV Catheter.
Data Provenance: The data provenance is internal to NuMED, Inc. (Hopkinton, NY, USA), with testing described as being performed in accordance with GMPs (Good Manufacturing Practices). This constitutes retrospective evaluation against established standards and comparison to a previously approved device. There is no indication of prospective patient data collection for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of information is not applicable to this submission. The ground truth for biocompatibility is established by standardized testing protocols (e.g., ISO standards referenced by the Tripartite Guidance). The ground truth for bench testing (e.g., burst pressure, dimensions) is established by engineering specifications and direct measurement, not expert consensus. For substantial equivalence, the "ground truth" is the established safety and effectiveness of the predicate device, which would have been determined at its time of approval.
4. Adjudication Method for the Test Set
Not applicable. There is no clinical test set requiring expert adjudication for this 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a physical medical device (catheter), not an AI/imaging diagnostic tool, and the submission is for substantial equivalence rather than a comparative clinical effectiveness trial. Therefore, an effect size of human readers improving with/without AI assistance is not relevant or provided.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone algorithm study was not done. This is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is established by:
- Predicate Device Equivalence: The primary ground truth is the established safety and effectiveness of the NuMED Z-MED PTV Catheter, to which the COEfficient PTV Catheter is demonstrated to be substantially equivalent.
- Standardized Bench Test Results: Objective measurements against engineering specifications (e.g., burst pressure, dimensions, inflation characteristics).
- Biocompatibility Standards: Compliance with recognized international and national guidelines for biocompatibility (Tripartite Biocompatibility Guidance).
There is no mention of expert consensus, pathology, or outcomes data from a clinical trial for establishing the ground truth for this specific submission, as it relies on equivalence to a predicate.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no training set for this device.
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SUMMARY OF SAFETY AND EFFECTIVENESS DATA
December 14, 2001
Submitted By: NuMED, Inc. , 2880 Main St., Hopkinton, NY 12965 (Ph) 315-328-4491
Contact Person: Nichelle LaFlesh
Device Name: NuMED COEfficient PTV Catheter; Class II
Predicate Devices: NuMED Z-MED PTV Catheter
Device Description: The COEfficient PTV Catheter is a coaxial over-the-wire catheter with a balloon near the distal tip. One lumen permits guidewire insertion to facilitate advancement of the catheter into the pulmonary valve while the other lumen is for balloon inflation and deflation. The balloon of the COEfficient model is made of a non-compliant polyethylene. The balloons are designed to inflate to a specific diameter at a given pressure. The change in diameter is minimal over the range of inflation pressures. The catheter body ends proximally in a bifurcated 'Y' connector with a guidewire port and a balloon extension. The balloon extension is marked with the product lot number and the balloon size. The outer body and inner body tubing is made of pebax. The area under the balloon is enhanced with either one or two radiopaque platinum image bands depending on the model. If marked with one image band, it is centered under the midpoint of the balloon. If it is marked with two image bands, they are located under the shoulders of the balloon. This catheter is of the same design and construction as the NuMED PTV catheters for which the 510(K) has been approved. The differences are lower profile, smaller shaft, and higher rated burst pressure.
Biocompatibility Testing: The materials used in the NuMED COEfficient Catheter are the same as those used in our other PTA Catheters (510(k) #K931009) and PTV Catheters (510(k) #K991977) which were tested for biocompatibility in compliance with the Tripatite Biocompatibility Guidance for Medical Devices.
Test results indicate that all materials demonstrate the biocompatibility of the NuMED catheter and are on file at NuMED, Inc.
Laboratory (Bench) Testing: All bench testing was performed in accordance with GMP's and the results are kept on file at NuMED, Inc.
Intended Use: This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.
- 에 A patient with isolated pulmonary stenosis
- A patient with valvular pulmonary stenosis with other minor congenital heart disease 미 that does not require surgical intervention.
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SPECIAL 510(K) - Confidential NuMED COEFFICIENT PTV Catheters
| Comparison Information:MODEL: | NUMED COEFFICIENT PTV | NUMED Z-MED PTV |
|---|---|---|
| Indications: | This catheter is recommended forPercutaneous TransluminalValvuloplasty (PTV) of the pulmonaryvalve.A patient with isolatedpulmonary stenosis A patient with valvularpulmonary stenosis with otherminor congenital heart diseasethat does not require surgicalintervention. | This catheter is recommended forPercutaneous TransluminalValvuloplasty (PTV) of thepulmonary valve.A patient with isolatedpulmonary stenosis A patient with valvularpulmonary stenosis withother minor congenital heartdisease that does not requiresurgical intervention. |
| Introducer: | 4 Fr - 7 Fr | 6 Fr - 14 Fr |
| Shaft Size: | 3.5 Fr | 5 Fr - 11 Fr |
| Guidewire Size: | 0.018" | 0.018", 0.021", 0.025", and0.035" |
| Usable Length: | 75 cm | 85 cm, 100 cm, 110 cm, and120cm |
| Balloon Diameter: | 4 mm - 12 mm | 2 mm - 20 mm, 22 mm - 26mm, 28 mm, 30 mm, 33 mm,35 mm, 35 mm, 40 mm. |
| Balloon Length: | 2 cm - 4 cm | 1 cm - 15 cm |
| Materials: | Shaft: PebaxBalloon: PES2Image Band: Platinum | Shaft: PebaxBalloon: PES2Image Band: Platinum |
| Construction: | Coaxial construction withdistally mounted non-compliantballoon. | Coaxial construction withdistally mounted non-compliantballoon. |
Comparison Information:
.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
APR 28 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Nichelle LaFlesh Regulatory Affairs Manager NuMED, Inc. 2880 Main St. Hopkinton, NY 12965
Re: K014124 COEfficient PTV Catheter Regulation Number: 21 CFR §870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: OMZ Dated: December 14, 2001 Received: December 17, 2001
Dear Ms. LaFlesh:
This letter corrects our substantially equivalent letter of January 16, 2002.
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 (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.
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
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Page 2 - Ms. Nichelle LaFlesh
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.
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 (240) 276-0120. 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/mdr/.
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,
una R. lochner
- Bram D. Zuckerman, M.D. Division Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
510(k) Number (if known): Device Name: NuMED COEfficient PTV Catheter
Indications For Use:
This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.
- A patient with isolated pulmonary stenosis 트
- A patient with valvular pulmonary stenosis with other minor congenital I heart disease that does not require surgical intervention.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K014184
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).