(30 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 is a coaxial lumen device with a semi-compliant balloon. The lumen marked "WIRE" is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.014 inch. The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. Two 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.
The provided text describes a Premarket Notification (510(k)) Summary for the AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through clinical studies with acceptance criteria in the traditional sense.
Therefore, many of the requested categories for acceptance criteria and study details are not applicable in this context. The "study" mentioned is primarily bench testing to support substantial equivalence for newly added balloon sizes, not a clinical trial evaluating diagnostic or treatment efficacy against specific performance metrics.
Here's an analysis based on the provided text, addressing the applicable points and explaining why others are not relevant:
Acceptance Criteria and Device Performance for AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter
1. A table of acceptance criteria and the reported device performance
In the context of a 510(k) for a device like a PTA balloon catheter, "acceptance criteria" are not typically expressed as performance metrics like sensitivity/specificity for a diagnostic device or success rates for a novel therapeutic device against predefined thresholds. Instead, the acceptance criteria revolve around demonstrating substantial equivalence to a predicate device, meaning it has the same intended use, similar technological characteristics, and performs as safely and effectively.
For this specific submission, the "performance" referenced primarily pertains to bench testing to support the substantial equivalence claim for the newly added balloon sizes. The document explicitly states: "Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the AMPHIRIONTM DEEP 0.014" OTW PTA Balloon Catheter meets the requirements that are considered acceptable for the intended use."
The document does not provide specific numerical acceptance criteria (e.g., burst pressure tolerance, deflation time) or reported performance values from these bench tests. It simply states that the tests were performed and support the claim.
| Acceptance Criteria Category (Implied by 510(k)) | Reported Device Performance (Summary) |
|---|---|
| Intended Use Equivalence | Same as predicate device (dilate stenoses in specified arteries and A-V fistulae). |
| Technological Characteristics Equivalence | Similar to predicate device (coaxial lumen, semi-compliant balloon, radiopaque markers, hydrophilic coating). Added balloon diameters (2.5mm, 3.0mm, 3.5mm, 4.0mm). |
| Material Equivalence | Same as predicate device. |
| Performance (Bench Testing) | Bench testing supports substantial equivalence for added balloon sizes. No specific numerical metrics reported in this summary. |
| Safety and Effectiveness | Deemed safe and effective based on substantial equivalence claim and supporting bench data. |
2. Sample size used for the test set and the data provenance
The document refers to "Performance testing (bench)."
- Sample Size for Test Set: Not specified. Bench tests often involve a certain number of units per size/configuration to ensure statistical validity, but the exact count is not disclosed in this summary.
- Data Provenance: The tests are "bench" tests, meaning in-vitro laboratory testing, not human or animal studies. Therefore, concepts like country of origin for patient data are not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For bench testing of a device like a balloon catheter, "ground truth" is typically defined by engineering specifications, material properties, and physical measurements, not by expert clinical consensus. The evaluation is against engineering standards and requirements, not expert interpretations of clinical data.
4. Adjudication method for the test set
Not applicable. As described above, the "test set" involves bench testing against engineering specifications, not clinical cases requiring expert 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
Not applicable. This device is a medical instrument (PTA balloon catheter), not a diagnostic imaging system or an AI-powered tool. Therefore, MRMC studies involving human readers or AI assistance are entirely irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
For the bench testing, the "ground truth" would be the engineering specifications and validated testing methodologies against which the device's physical properties and performance characteristics (e.g., burst pressure, inflation/deflation times, guidewire compatibility, shaft flexibility) are measured. These are objective measurements compared to predefined limits and the predicate device's performance.
8. The sample size for the training set
Not applicable. This is a 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. See point 8.
{0}------------------------------------------------
FEB 1 ] 2005
| Premarket Notification (510(k)) Summary |
|---|
| ------------------------------------------------ |
| 510(k) Number: | K050013 |
|---|---|
| Product Name: | AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter |
| Common Name: | Peripheral Transluminal Angioplasty Catheter |
| Class: | Class II, 21 CFR Sec 870.1250, Product Code DQY |
| Submitter's Name: | ev3 Inc.4600 Nathan Lane NorthPlymouth, MN 55442 |
| Official Contact: | Mike WinegarVP, International Regulatory AffairsTelephone: 763-398-7225 |
| Summary Preparation Date: | January 10, 2005 |
This summary is provided in compliance with section 513(I)(3)(A) of the Act and summarizes the safety and effectiveness information contained in this premarket notification submission for a modification to the AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter
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 is a coaxial lumen device with a semi-compliant balloon. The lumen marked "WIRE" is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.014 inch. The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. Two 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.
The modified device is substantially equivalent* to the currently marketed PTA balloon catheter in intended use, materials, technological characteristics and performance. Balloon diameters of 2.5 mm, 3.0 mm, 3.5 mm, and 4.0 mm are being added to the product line. Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the AMPHIRIONTM DEEP 0.014" OTW PTA Balloon Catheter meets the requirements that are considered acceptable for the intended use.
*This document uses the term "substantial equivalence" as intended in 21 CFR 807.87, and not as defined in Title 35 of the US Code.
{1}------------------------------------------------
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
FEB 1 1 2005
ev3 Inc. c/o Mr. Mike Winegar Vice President, International Regulatory Affairs 4600 Nathan Lane North Plymouth, MN 55442
Re: K050073
Trade Name: AMPHIRION DEEP PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II (two) Product Code: DQY Dated: January 10, 2005 Received: January 12, 2005
Dear Mr. Winegar:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bectorn of the device 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 manage of the Medical Device American son to commerce prior to May 20, 1970, the excordance with the provisions of the Federal Food, Drug, de necs marchave been reciasined in quire approval of a premarket approval application (PMA). and Cosmetic Act (710) that the device, subject to the general controls provisions of the Act. The I ou may, merciolore, manot the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is classified (see above) and . Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Obecaments concerning your device in the Federal Register.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
{2}------------------------------------------------
Page 2 - Mr. Mike Winegar
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advised that I Dri 3 losames or our device complies with other requirements of the Act that I DA has made a seterminations administered by other Federal agencies. You must or any I catal suttated and regulaments, including, but not limited to: registration and listing (21 Comply with an the Not 8 requirements, we sees manufacturing practice requirements as set OFIC art 607), mooning (21 CFR Part 820); and if applicable, the electronic forth in the quarty systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro tegin marketing your device as described in your Section 510(k) I mis icher will anow you to ogin mailing of substantial equivalence of your device to a legally prematicate device results in a classification for your device and 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 at not 12-1 - 1 240) 276-0120. Also, please note the regulation entitled, Contact the Office of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour Coll.
Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Duva R. Kirchner
Image /page/2/Picture/5 description: The image contains a signature. The signature is illegible, but it appears to be written in cursive. The signature is located on a white background. The signature is written in black ink.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known): Ko 50073
Device Name:
AMPHIRION DEEP™ Peripheral Transluminal Angioplasty (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 X AND/OR (Part 21 CFR 801 Subpart D)
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)
Dona P. Lochner
(Division Sign-Off) Division or Cardiovascular Devices
510(k) Number_KU 5 66 7 3
Page 1 of
§ 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).