(226 days)
The Medtronic AVE Solstice™ Solstice Balloon Temporary Occlusion System is intended to be used for temporary vascular occlusion in selectively stopping or controlling blood flow in the peripheral, cerebral, and visceral vasculature.
The Solstice is a single lumen balloon catheter that uses the QS 10 guidewire to occlude the central lumen and allow inflation of the balloon. This is accomplished by advancing any part of the QS 10 through the catheter. The single lumen then becomes occluded allowing fluid to fill the balloon.
The Medtronic AVE Solstice™ Temporary Occlusion Balloon System (K994141) is a medical device designed for temporary vascular occlusion. This document summarizes the acceptance criteria and the study used to establish its substantial equivalence to a predicate device.
1. Acceptance Criteria and Reported Device Performance
The provided text, a Summary of Safety and Effectiveness for a 510(k) submission, describes the general approach to demonstrating safety and effectiveness rather than a specific table of acceptance criteria with numerical performance targets. The overall acceptance criteria are implied to be achieving equivalence in intended use, design, and physical characteristics to the predicate device, the MTI Equinox™ Occlusion Balloon System (K990487).
The reported device performance is stated broadly: "Based on in-vitro and in vivo testing results, Medtronic AVE believes the Solstice and QS 10 are safe and effective for their intended use."
To provide a structured table, we can infer the categories of acceptance criteria based on the testing performed.
| Acceptance Criteria Category | Reported Device Performance (Implied) |
|---|---|
| Biocompatibility | Device demonstrates acceptable biocompatibility, indicating it is safe for contact with biological systems and does not elicit adverse reactions. |
| Reliability | Device exhibits satisfactory reliability, suggesting consistent performance over its expected lifespan and under various conditions. |
| Mechanical Properties | Solstice Catheter and QS 10 Guidewire meet specified mechanical performance requirements (e.g., strength, flexibility, inflation/deflation). |
| In-vitro Performance | Laboratory testing confirms the device functions as intended for temporary occlusion in simulated environments. |
| In-vivo Performance | Animal studies confirm the device's ability to safely and effectively achieve temporary vascular occlusion within a living system. |
2. Sample Size and Data Provenance
The provided text does not specify the exact sample sizes used for the "physical bench testing," "biocompatibility," and "animal studies." It states that "Testing was conducted on final, testing, mounted catheters and QS 10 Guidewires."
The data provenance is not explicitly stated in terms of country of origin. The studies are described as "animal studies" and "in-vitro testing," suggesting laboratory and preclinical environments. The nature of the submission (510(k)) implies the data is retrospective, as it was gathered prior to the submission for regulatory clearance.
3. Number of Experts and Qualifications for Ground Truth
The provided text does not mention the use of experts to establish a "ground truth" in the context of human-readable data (e.g., image interpretation). The evaluation focuses on the physical and biological performance of the device through bench and animal testing. Therefore, this section is not applicable in the context of the provided information. If this were a clinical study with human outcomes data requiring expert interpretation, then such information would be relevant.
4. Adjudication Method
Since the assessment is based on physical bench testing, biocompatibility, and animal studies, and not on human-interpreted data, an "adjudication method" as typically understood in clinical trials (e.g., 2+1 reading) is not applicable. The assessment would have been based on pre-defined test protocols and measurable outcomes from the various tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study is not applicable to this device. This type of study is typically used for diagnostic or screening devices where human readers interpret images or other data, and the focus is on how an AI system might improve human performance. The Medtronic AVE Solstice™ is an interventional device, and its evaluation is based on its physical properties and in-vivo performance, not human interpretive accuracy.
6. Standalone (Algorithm Only) Performance
A standalone performance evaluation (algorithm only, without human-in-the-loop) is not applicable for this device. The device itself is a physical medical instrument, not an AI algorithm. Its performance is inherent to its design and manufacturing, evaluated through physical, chemical, and biological testing, not through algorithmic output.
7. Type of Ground Truth Used
For the safety and effectiveness studies, the "ground truth" was established through:
- Bench Test Results: Measurable physical and mechanical properties of the device (e.g., balloon inflation/deflation times, material strength, integrity under stress).
- Biocompatibility Standards: Compliance with established biological safety standards for medical devices (e.g., lack of cytotoxicity, sensitization, irritation).
- Physiological Outcomes in Animal Models: Direct observable and measurable effects in living animal models (e.g., successful vascular occlusion, no adverse tissue reactions, patency after occlusion removal).
These are objective, direct measurements and observations, not expert consensus on an interpretation of data.
8. Sample Size for the Training Set
The concept of a "training set" is primarily relevant for AI/ML algorithms. Since this is a physical medical device and not an AI solution, there is no training set in the traditional sense. The manufacturing process and quality control would involve statistical sampling during production and validation, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set was Established
As there is no "training set" for an AI algorithm, this question is not applicable. The "ground truth" for the device's performance was established through rigorous physical, chemical, and biological testing according to established medical device standards and protocols, as outlined in earlier sections.
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Summary of Safety and Effectiveness
Trade Name:
Medtronic AVE Solstice ™ Temporary Occlusion Balloon System.
Manufacturer:
Medtronic AVE, Inc. 3576 Unocal Street Santa Rosa, California, 95403
Contact: Sonny Yamasaki
Establishment Registration Number: 2953200
Classification Name:
Catheter, Intravascular Occluding, Temporary (21 CFR 870.4450) Wire, Guide, Catheter (21 CRF 870.1330)
Device Classification:
Solstice: Class II (21 CFR 870.4450) Panel: Interventional Cardiovascular DCRND QS 10: Class II (21 CFR 870.1330) Panel: Interventional Cardiovascular DCRND
Intended Use and Product Description:
The Medtronic AVE Solstice Temporary Occlusion Balloon Catheter and QS 10 Guidewire System (here after referred to as Solstice and/or QS 10) is designed for use in blood vessels where temporary occlusion is desired. Solstice and QS 10 are intended to be used together for temporary vascular occlusion in selectively stopping or controlling blood flow in the peripheral, cerebral, and visceral vasculature.
The Solstice is a single lumen balloon catheter that uses the QS 10 guidewire to occlude the central lumen and allow inflation of the balloon. This is accomplished by advancing any part of the QS 10 through the catheter. The single lumen then becomes occluded allowing fluid to fill the balloon.
Sterilization, Packaging, and Pyrogenicity:
The Solstice Temporary Occlusion Balloon System is packaged in individual dispensing hoops which are sealed inside their own labeled Tyvek bags, The Solstice System is created by placing a Solstice sterile pouch, a QS 10 Guidewire sterilized pouch and the IFUs (one for Solstice and one for QS 10) in a carton with a Solstice System Label. QS 10 Guidewire packaging has also been validated for being sold individually.
Solstice Catheter is sterilized using EtO and the QS 10 is e-beam irradiation sterilized.
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Substantial Equivalence:
The Medtronic AVE Solstice Temporary Occlusion Balloon System is substantially rno Wouth to the MTI, Equinox™ Occlusion Balloon System (K990487) which includes a 0.10" guide wire (SilverSpeed: K982543)
Establishment of equivalence is based on similarities of intended use, design, and physical characteristics as evaluated by physical bench testing, biocompatibility, and animal studies.
Summary of Safety and Effectiveness:
Safety and effectiveness were evaluated through biocompatibility testing, reliability testing, mechanical testing, and animal studies. Testing was conducted on final, testing, mountined to atheters and QS 10 Guidewires with guidance in part from "PTCA Catheters Atherectorny Catheters Lasers Intravascular Stents," May 1995. The tests were used to assess the mechanical properties of the Solstice Catheter and QS 10 Guidewire. Based on in-vitro and in vivo testing results, Medtronic AVE believes the Solstice and QS 10 are safe and effective for their intended use.
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Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 1 2000
Sonny Yamasaki, Ph.D. Medtronic AVE, Inc. 3576 Unocal Street Santa Rosa, CA 95403
Re: K994141 Medtronic AVE Solstice™ Temporary Occlusion Balloon System Regulatory Class: II (two) Product Code: 74 MJN Dated: April 28, 2000 Received: May 1, 2000
Dear Dr. Yamasaki:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to The general controls the general controls provisions of the Act. 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Sonny Yamasaki, Ph.D.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Brim E. Harvey
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation enter for Devices and Radiological Health
Enclosure
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INDICATION FOR USE STATEMENT
Company Name:
Medtronic AVE
Device Name:
Indication for Use:
Solstice™ Balloon Temporary Occlusion Catheter Balloon System
The Medtronic AVE Solstice™ Solstice Balloon Temporary Occlusion System is intended to be used for temporary vascular occlusion in selectively stopping or controlling blood flow in the peripheral, cerebral, and visceral vasculature.
Bin E. Hansen
K994141
ﺮ ﺍﻟﻤ
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).