(5 days)
Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters are recommended for Percutaneous Transluminal Angioplasty of small, narrowed or obstructed iliac, femoral, or renal vessels in the peripheral vasculature.
The Symmetry Balloon Dilatation Catheter is an over-the-wire catheter offered in a three lumen catheter shaft design. One lumen, marked "distal", is the central lumen of the catheter which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire. The Symmetry device is designed to be placed over guidewires which have outer diameters of 0.018" or smaller. The lumen marked "balloon" is comprised of two smaller, separate lumens which both communicate with the balloon at one end and terminate in a single balloon hub and lead tube at the proximal end of the device. The Symmetry device is offered in both standard and stiff shaft versions.
The provided document does not contain information regarding detailed acceptance criteria or the specific studies conducted to demonstrate the device meets those criteria. The submission, K060959, is a 510(k) summary for the "Symmetry Balloon Dilatation Catheter."
Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Symmetry Balloon Dilatation Catheter K953602, cleared October 18, 1995). The basis for this equivalence is explicitly stated as:
- Identical device materials and design characteristics.
- The only change being initiated is to add a single warning to the Directions for Use.
Therefore, there is no mention of performance metrics, sample sizes, expert ground truth, or statistical studies typically associated with proving a device meets specific acceptance criteria in the manner requested. The substantial equivalence pathway relies on the prior clearance of the predicate device.
To directly answer your specific questions based only on the provided text:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as performance metrics. The underlying acceptance criterion for this 510(k) is "substantial equivalence" to the predicate device. This implies that the device must be safe and effective for its intended use, as demonstrated by the predicate.
- Reported Device Performance: Not provided. The submission states "identical device materials and design characteristics," implying performance is expected to be the same as the predicate.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable as no specific test set or performance data is presented for this 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable as no specific test set or human evaluation is presented.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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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 not an AI/software device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable; this is not an AI/software device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The ground for clearance is based on the substantial equivalence to a legally marketed predicate device, rather than new "ground truth" establishment for this specific submission.
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The sample size for the training set:
- Not applicable as no training set for an algorithm is mentioned.
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How the ground truth for the training set was established:
- Not applicable.
In summary: K060959 is a 510(k) submission that relies on the "substantial equivalence" pathway for regulatory clearance. It asserts that the proposed device is substantially equivalent to a predicate device due to identical materials, design, and indications for use, with only a minor labeling change. Therefore, it does not detail new performance studies, acceptance criteria, or ground truth establishment as would be required for a novel device or a device demonstrating new performance claims.
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APR 1 2 2006
510(k) Summary
per 21 CFR §807.92
| Submitter's Nameand Address | Boston Scientific CorporationTwo Scimed PlaceMaple Grove, MN 55311 |
|---|---|
| Contact Name andInformation | Angela BylandManager, Regulatory AffairsPhone: (763) 494-2887Fax: (763) 494-2981 |
| Date Prepared | April 6, 2006 |
| ProprietaryName(s) | Symmetry Balloon Dilatation Catheter |
| Common Name | Balloon Dilatation Catheter |
| Product Code | LIT |
| Classification ofDevice | Class II, 21 CFR Part 870.1250 |
| Predicate Device | Symmetry Balloon Dilatation Catheter K953602 October 18, 1995 |
| DeviceDescription | The Symmetry Balloon Dilatation Catheter is an over-the-wire catheter offered in a three lumen catheter shaft design.One lumen, marked "distal", is the central lumen of thecatheter which terminates at the distal tip. This lumen isused to pass the catheter over a guidewire. The Symmetrydevice is designed to be placed over guidewires which haveouter diameters of 0.018" or smaller. The lumen marked"balloon" is comprised of two smaller, separate lumenswhich both communicate with the balloon at one end andterminate in a single balloon hub and lead tube at theproximal end of the device.The Symmetry device is offered in both standard and stiffshaft versions. |
| Intended Use ofDevice | Symmetry and Symmetry Stiff Shaft Balloon DilatationCatheters are recommended for Percutaneous TransluminalAngioplasty of small, narrowed or obstructed iliac, femoral,or renal vessels in the peripheral vasculature. |
| Comparison ofTechnologicalCharacteristics | The materials and design of the Symmetry balloon dilatationcatheter are equivalent to the predicate Symmetry Balloondilatation catheter. |
| Support ofSubstantialEquivalence | Boston Scientific Corporation considers the proposedSymmetry Balloon Dilatation Catheter to be substantiallyequivalent to the existing Symmetry Balloon DilatationCatheter (K953602 cleared October 18, 1995). Thisassessment is based upon identical device materials anddesign characteristics and the only change being initiated isto add a single warning to the Directions for Use. |
| Conclusion | Based on the indications for use and the technologicalcharacteristics, the Symmetry Balloon Dilatation Catheterhas been shown to be equivalent in intended use and isconsidered to be substantially equivalent to the SymmetryBalloon Dilatation Catheter (K000798; cleared October 18,1995). |
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APR 1 2 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific Corporation c/o Ms. Angela Byland Manager, Regulatory Affairs Two Scimed Place Maple Grove, MN 55311-1566
Re: K060959
Symmetry Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Angioplasty, Peripheral, Transluminal Regulatory Class: Class II Product Code: LIT Dated: April 6, 2006 Received: April 7, 2006
Dear Ms. Byland:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
R.Z. M.P.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number:
Symmetry Balloon Dilatation Catheter Device Name:
Indications for Use:
Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters are recommended for Percutaneous Transluminal Angioplasty of small, narrowed or obstructed iliac, femoral, or renal vessels in the peripheral vasculature.
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)
Division Sign-Off) If Cardiovascular Devices Division o
510(k) Number K060957
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).