(105 days)
The AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The AMPHIRION DEEP catheter has a semi-compliant inflatable balloon mounted at the distal tip. It has a coaxial lumen. The central lumen of the catheter, which terminates at the distal tip, is used to pass the catheter over a guidewire with a maximum outer diameter of 0.014 inch. The other lumen is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. Radiopaque marker bands are placed under the balloon segment of the catheter shaft to provide visual reference points for balloon positioning within the vessel. The distal catheter shaft is hydrophilic coated (balloon included). The AMPHIRION DEEP catheter is available in different balloon sizes (balloon diameters of 1.5 and 2.0 mm and balloon lengths of 20, 40, 80 and 120 mm). Nominal balloon diameter and length are printed on the hub. The maximum recommended guidewire diameter is 0.014" and the usable catheter length is 120cm.
The provided document is a 510(k) summary for the AMPHIRION™ DEEP 0.014" OTW PTA BALLOON CATHETER, a medical device. This type of document is for a medical device that does not use AI/ML technology, and therefore, many of the requested categories are not applicable. The document describes the device, its intended use, and how its safety and effectiveness were demonstrated through in-vitro testing and comparison to predicate devices, rather than a study with acceptance criteria and device performance as typically understood for AI/ML devices.
Here's an attempt to answer the questions based on the provided text, noting where information is not applicable or unavailable:
1. Table of acceptance criteria and the reported device performance
Since this is a physical medical device (a catheter) and not an AI/ML device, the "acceptance criteria" and "reported device performance" are based on a series of in-vitro physical tests designed to ensure the device meets engineering specifications and safety standards, rather than diagnostic accuracy metrics.
| Acceptance Criteria (Tests Performed) | Reported Device Performance |
|---|---|
| Balloon Compliance | Demonstrated, indicating balloon inflates as expected. |
| Balloon Burst Pressure | Demonstrated, ensuring balloon can withstand pressure. |
| Balloon Fatigue | Demonstrated, indicating durability under repeated use. |
| Shaft Burst Pressure | Demonstrated, ensuring shaft integrity under pressure. |
| Bond Strength | Demonstrated, ensuring structural integrity of components. |
| Catheter Dimensions | Demonstrated, meeting specified dimensions. |
| Guidewire Compatibility | Demonstrated, compatible with 0.014-inch guidewires. |
| Introducer Compatibility | Demonstrated, compatible with introducer sheaths. |
| Biocompatibility | All materials proved biocompatible based on test results. |
2. Sample sized used for the test set and the data provenance
For physical medical devices, "test set" typically refers to the number of individual devices or components subjected to specific physical bench tests. The document does not specify the exact sample sizes (e.g., number of catheters tested for burst pressure), nor does it describe data provenance in terms of country of origin or retrospective/prospective, as these concepts are not applicable to the in-vitro mechanical and material tests described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for physical device testing is established by engineering specifications, material standards, and validated testing methodologies, not by expert consensus on clinical data.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical data interpretation or labeling decisions, typically involving multiple human readers to establish a consensus ground truth. This is not relevant for the in-vitro physical testing of a catheter.
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
Not applicable. This is a physical medical device, not an AI/ML diagnostic tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
For this device, the "ground truth" for demonstrating safety and effectiveness was based on:
- Engineering Specifications: Performance metrics (e.g., burst pressure, dimensions) were compared against predefined engineering and design specifications.
- Material Standards: Biocompatibility testing followed established material science standards.
- Predicate Device Equivalence: Performance was deemed "substantially equivalent" to legally marketed predicate devices through comparison of physical characteristics and mechanical testing data.
8. The sample size for the training set
Not applicable. This is a physical medical device, and the concept of a "training set" is not relevant.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth establishment for it.
Summary regarding AI/ML relevance:
The provided document describes a traditional 510(k) submission for a physical medical device (PTA balloon catheter). It focuses on demonstrating substantial equivalence to predicate devices through physical characteristics (design, materials, dimensions) and in-vitro performance testing (e.g., burst pressure, biocompatibility). None of the information suggests the involvement of AI/ML technology, hence many of the questions regarding AI/ML study design and performance metrics are not applicable.
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K04262 y
510(k) Summary AMPHIRION™ DEEP 0.014" OTW PTA BALLOON CATHETER
| 510(k) Summary | This summary of 510(k) Safety and Effectiveness information isbeing submitted in accordance with the requirements of 21 C.F.R §807.92. |
|---|---|
| Applicant(Manufacturer) | Invatec Innovative Technologies, s.r.l.Via Martiri della Libertà, 725030 Roncadelle (BS) ItalyTel: +39 030 258 93 11Fax: +39 030 258 93 12www.invatec.cominfo@invatec.com |
| Submitter | ev3 Inc.4600 Nathan Lane NorthPlymouth, MN 55442Tel: (763) 398 7000Fax: (763) 398 7200 |
| Contact Person | Mike WinegarTel: (763) 398-7225Fax: (763) 398-7200E-mail: mwinegar@ev3.net |
| Date Prepared | September 24th, 2004 |
| Device Trade Name | AMPHIRIONTM DEEP 0.014" OTW PTA BALLOON CATHETER |
| Device Common Name | Peripheral Transluminal Angioplasty (PTA) Catheter |
| Classification Name | 21 CFR 870.1250 Percutaneous Catheter |
| Device Classification | Regulatory Class: Class IIProduct Code: LIT |
| Classification Panel | Cardiovascular |
| Predicate Devices | Boston Scientific SYMMETRYTM Small Vessel Balloon DilatationCatheterCordis AVIATORTM Peripheral Dilatation Catheter |
| Intended Use | The AMPHIRIONTM DEEP 0.014" OTW PTA BALLOONCATHETER is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for thetreatment of obstructive lesions of native or synthetic arteriovenousdialysis fistulae. |
| Device Description | The AMPHIRION DEEP catheter has a semi-compliant inflatable balloon mounted at the distal tip. It has a coaxial lumen. The central lumen of the catheter, which terminates at the distal tip, is used to pass the catheter over a guidewire with a maximum outer diameter of 0.014 inch. The other lumen is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. Radiopaque marker bands are placed under the balloon segment of the catheter shaft to provide visual reference points for balloon positioning within the vessel. The distal catheter shaft is hydrophilic coated (balloon included). The AMPHIRION DEEP catheter is available in different balloon sizes (balloon diameters of 1.5 and 2.0 mm and balloon lengths of 20, 40, 80 and 120 mm). Nominal balloon diameter and length are printed on the hub. The maximum recommended guidewire diameter is 0.014" and the usable catheter length is 120cm. |
| Biocompatibility | All material used in the AMPHIRION DEEP catheter are biocompatible, based on test results. |
| Performance Data | In-vitro testing was conducted to demonstrate the safety and effectiveness of the AMPHIRION DEEP catheter. This testing included balloon compliance, balloon burst pressure, balloon fatigue, shaft burst pressure, bond strength, catheter dimensions and guidewire and introducer compatibility. |
| Summary of SubstantialEquivalence | The AMPHIRION DEEP catheter is similar to the predicates with respect to intended use and with respect to physical characteristics, such as catheter and balloon dimensions and catheter design and materials. The AMPHIRION DEEP catheter is therefore substantially equivalent to the predicate devices. Mechanical and biocompatibility testing data is indicative of the safety and effectiveness of the AMPHIRION DEEP catheter. Therefore, based on its own performance characteristics and the technological similarities, the AMPHIRION DEEP catheter is expected to perform similar to the predicate devices and other comparable, currently marketed PTA catheters. |
| Conclusion | The AMPHIRION DEEP catheter is substantially equivalent to the predicate devices and other currently marketed PTA catheters. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping chevrons or swooshes, creating a sense of movement or flow.
JAN 1 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ev3 Inc. c/o Mr. Mike Winegar Vice President, International Regulatory Affairs 4600 Nathan Lane North Plymouth, MN 55442
Re: K042624 Trade Name: AMPHIRION DEEP PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II (two) Product Code: DQY Dated: September 24, 2004 Received: September 27, 2004
Dear Mr. Winegar:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 9 rotty premeined is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regally manatis and the Medical Device American so to commerce prior to May 28, 1976, the encordance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the dis devices that have been icclassified in accercance was a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval one You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, merciole, market the device, experients for annual registration, listing of general controls provisions of the 120 labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is crassified (see above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller a Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous of concerning your device in the Federal Register.
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Page 2 – Mr. Mike Winegar
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a succession requirements of the Act
that FDA has made a determination that your device complies with other matt that FDA has made a determination that your active federal agencies. You must of any Federal statutes and regulations annualines but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 820); good if applicable, the electronic Iorni in the quality systems (QD) regalates (Sections 531-542 of the Act); 21 CFR 1000-1050. product fadiation control provisions (Decleons De Levice as described in your Section 5 10(k) I his letter will anow you to begin manceing your and equivalence of your device to a legally premarket nothication. The PDA maing of backers on the said thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific arvice for your as 1100 % 276-0120. Also, please note the regulation entitled, p Colliact the Office of Complians as (21 trip Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-204 or Manufacturers, International and Oolisanter : 16www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Danna R. Victines
Bram D. Zuckerman, M.D. ﮐﮯ 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: KC)42624
Device Name: AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter
Indications For Use:
The AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muna R. Vochner
(Division Sign-Off)
ovision of Cardiovascular Devices
510(k) Number_KO
Page 1 of f
§ 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).