(65 days)
Balloon Dilatation Catheters are recommended for Percutaneous Transluminal Angioplasty of the Iliac, Femoral and Renal Arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Blue MaxTM Balloon Dilatation Catheter, styled after the Gruentzig technique, is a double lumen catheter with a non-compliant balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow vessel segments. The Blue MaxTM balloon dilation catheter is designed to deliver maximum force in calcified or fibrotic lesions, or in lesions or strictures that are resistant to dilatation. The Catheter body has two lumens. The 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 lumen can also be used for infusion of contrast medium. The lumen marked "Balloon" is the balloon inflation lumen. The catheter shaft tapers beneath the balloon segment to achieve the lowest possible deflated profile. Radiopaque markers are placed under the balloon segment of the catheter to provide visual reference points for balloon positioning within the vessel. Each balloon inflates to its stated diameter and length over a range of 4 atm (405 kPa) to its rated burst pressure. The minimal dilating force required to dilate should be applied, minimizing risks of balloon over-inflation or rupture.
The provided 510(k) summary (K07/309 for the Blue MaxTM Balloon Dilatation Catheter) does not describe an AI-powered device or a study involving acceptance criteria for device performance based on metrics like sensitivity, specificity, or AUC. The submission focuses on establishing substantial equivalence to a predicate device, which is a common pathway for medical devices that are not significantly different from already approved devices.
Instead of clinical performance criteria, the "acceptance criteria" for this device are related to manufacturing specifications and functional performance of the balloon catheter itself, ensuring it meets its intended design. The "study" mentioned is a demonstration of these physical characteristics rather than a clinical trial or AI model validation study.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the statement: "Each balloon inflates to its stated diameter and length over a range of 4 atm (405 kPa) to its rated burst pressure." This indicates that the device must perform according to its specified dimensions and pressure capabilities.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Inflation to stated diameter | Balloon inflates to its stated diameter (implied conformance) |
| Inflation to stated length | Balloon inflates to its stated length (implied conformance) |
| Inflation over pressure range | Inflation occurs over a range of 4 atm (405 kPa) to rated burst pressure (implied conformance) |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not mention a "test set" in the context of clinical data or patient samples. The assessment is based on the device's physical characteristics. Therefore, there is no information about data provenance (e.g., country of origin, retrospective/prospective). The "study" would have involved testing units of the catheter to verify their physical performance. The sample size for such engineering tests is not disclosed but would typically be a statistical sample of manufactured units.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device is a physical medical device, not an AI or diagnostic tool requiring expert ground truth for a test set. The validation would be based on engineering specifications and testing.
4. Adjudication Method for the Test Set
This information is not applicable. There is no "adjudication" in the context of a clinical test set for this type of device.
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
This information is not applicable. This is not an AI-powered device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an AI-powered device, so there is no algorithm or standalone performance to evaluate.
7. The Type of Ground Truth Used
The "ground truth" for this device is its design specifications and physical performance characteristics. For example, the "ground truth" for its diameter is the manufacturing specification for that diameter, and the "ground truth" for its inflation pressure range is the specified functional range.
8. The Sample Size for the Training Set
This information is not applicable. This is not an AI-powered device, and therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set.
Summary of the Study Proving Device Meets Acceptance Criteria:
The provided document describes a 510(k) submission for the Blue MaxTM Balloon Dilatation Catheter. The primary "study" or justification for approval is based on demonstrating substantial equivalence to a previously cleared predicate device (Blue Max™ Balloon Dilatation Catheter cleared April 13, 2000, K000570).
The core of this submission is not about clinical effectiveness or advanced performance metrics but rather confirming that the materials and design characteristics of the new device are identical to those of the predicate. The only change mentioned is the addition of a contraindications section and moving existing precautions in the Directions for Use.
Therefore, the "proof" that the device meets "acceptance criteria" is an assertion of its identical nature to an already approved device and its ability to meet standard engineering and functional specifications for balloon catheters (e.g., inflation to stated diameter and length within a specified pressure range), which are implied to have been verified through internal testing (though no specific study protocol or data is included in this summary). This type of submission relies heavily on the established safety and effectiveness of the predicate device.
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K07/309
510(k) Summary
Per 21 CFR §807.92
JUL 1 3 2007
| Submitter's Nameand Address | Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311 |
|---|---|
| Contact Name andInformation | Kari ChristiansonRegulatory Affairs SpecialistPhone: (763) 494-1969Fax: (763) 494-2222 |
| Date Prepared | May 07, 2006 |
| ProprietaryName(s) | Blue MaxTM Balloon Dilatation Catheter |
| Common Name | Balloon Dilatation Catheter |
| Product Code | LIT |
| Classification ofDevice | Class II, 21 CFR Part 870.1250 |
| Predicate Device | Blue MaxTM Balloon Dilatation Catheter |
| DeviceDescription | The Blue MaxTM Balloon Dilatation Catheter, styled after theGruentzig technique, is a double lumen catheter with a non-compliant balloon mounted at the distal tip. Dilatationballoon catheters are used to exert radial force to dilatenarrow vessel segments. The Blue MaxTM balloon dilationcatheter is designed to deliver maximum force in calcified orfibrotic lesions, or in lesions or strictures that are resistant to |
| Device | Catheter Construction |
| Description(continued) | The Catheter body has two lumens. The lumen marked"distal" is the central lumen of the catheter which terminatesat the distal tip. This lumen is used to pass the catheter over aguidewire. The lumen can also be used for infusion ofcontrast medium.The lumen marked "Balloon" is the balloon inflation lumen.The catheter shaft tapers beneath the balloon segment toachieve the lowest possible deflated profile.Radiopaque markers are placed under the balloon segment ofthe catheter to provide visual reference points for balloonpositioning within the vessel. |
| Intended Use ofDevice | Blue Max™ Balloon Dilatation Catheters are recommendedfor Percutaneous Transluminal Angioplasty of the Iliac,Femoral, and Renal Arteries and for the treatment ofobstructive lesions of native or synthetic arteriovenousdialysis fistulae. |
| Comparison ofTechnologicalCharacteristics | The materials and design of the Blue Max™ BalloonDilatation Catheter are equivalent to the predicate Blue MaxBalloon Dilatation Catheter. |
| Support ofSubstantialEquivalence | Boston Scientific Corporation considers the proposed BlueMax™ Balloon Dilatation Catheter to be substantiallyequivalent to the existing Blue Max™ Balloon DilatationCatheter (K000570 cleared April 13, 2000). This assessmentis based upon identical device materials and designcharacteristics. The only change being initiated is to add acontraindications section to the Directions for Use, andmove three existing precautions to this new section. |
| Conclusion | Based on the indications for use and the technologicalcharacteristics, the Blue Max™ Balloon Dilatation Catheterhas been shown to be equivalent in intended use and isconsidered to be substantially equivalent to the Blue Max™ |
Balloon Construction
dilatation.
Each balloon inflates to its stated diameter and length over a range of 4 atm (405 kPa) to its rated burst pressure. The minimal dilating force required to dilate should be applied, minimizing risks of balloon over-inflation or rupture.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 3 2007
Boston Scientific Corp. c/o Ms. Kari Christianson One Scimed Place A380 Maple Grove, MN 55311-1566
Re: K071309
Trade/Device Name: Blue Max™ Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter Regulatory Class: Class II (Two) Product Code: LIT Dated: May 7, 2007 Received: May 9, 2007
Dear Ms. Christianson:
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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Page 2 - Ms. Kari Christianson
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 (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. 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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
R. bohner
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:
KO71309
Blue Max™ Balloon Dilatation Catheter Device Name:
Indications for Use:
Balloon Dilatation Catheters are recommended for Percutaneous Transluminal Angioplasty of the Iliac, Femoral 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)
Duma R. Lochner
(Divic. Off)
Cardiovascular Devices
Number K071309
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).