(21 days)
Contour SETM Microspheres are indicated for use for the embolization of hypervascular tumors and arteriovenous malformations.
The Contour SE TM Microspheres are spherical embolic particles and are available in a variety of particle sizes and are indicated for use for the embolization of hypervascular tumors and arteriovenous malformations. These particles are provided in a sterilized syringe.
The provided text is a 510(k) Summary for the Contour SE™ Microspheres. It states that the device has been tested for biocompatibility per ISO 10993 and demonstrated to be substantially equivalent to predicate devices. However, the document does NOT contain explicit acceptance criteria or a detailed study description with performance metrics in the format requested.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of specific performance thresholds (e.g., "particle size must be within X um"). The document states the device has been tested for biocompatibility per Biocompatibility ISO 10993 and that all data demonstrate this device is biocompatible for its intended use. It also states the device has been tested and compared to the Summary of Substantial predicate device and all data gathered demonstrate this device as substantially Equivalent equivalent. No new issues of safety or efficacy have been raised.
- Reported Device Performance: The only "performance" reported is compliance with biocompatibility standards and substantial equivalence to predicate devices, but no specific quantitative metrics are provided.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Biocompatibility per ISO 10993 | Device is biocompatible for its intended use. |
| Substantial Equivalence to Predicate Devices (Contour® Emboli PVA, Embosphere Microspheres, EmboGold Microspehers) | Substantially equivalent. No new issues of safety or efficacy. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified.
3. 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 this is a device for embolization, not an diagnostic imaging AI. The "ground truth" here would relate to device properties (e.g., particle size, mechanical integrity, biocompatibility) rather than diagnostic interpretations. No experts are mentioned in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified.
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
- No, this is not an AI/software device. It's a medical device (microspheres for embolization).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not an AI/software device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For biocompatibility: Adherence to ISO 10993 standards and a review of test results (likely chemical analysis, in vitro cytotoxicity, sensitization, irritation tests).
- For substantial equivalence: Comparison of characteristics (e.g., material, dimensions, intended use, manufacturing process, physical properties) with predicate devices.
8. The sample size for the training set
- Not applicable, as this is not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable, as this is not a machine learning model.
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SEP 2 3 2003
510(k) Summary K032707
| GeneralProvisions | Trade Name: Contour SETM Microspheres |
|---|---|
| Classification Name: Artificial Embolization Device | |
| DeviceDescription/Indications forUse | The Contour SE TM Microspheres are spherical embolic particles and areavailable in a variety of particle sizes and are indicated for use for theembolization of hypervascular tumors and arteriovenous malformations.These particles are provided in a sterilized syringe. |
| Data SummaryPrepared | September 16, 2003 |
| Contact Name/Number | Jodi Lynn GreenizenRegulatory Affairs Project ManagerBoston Scientific Corporation10 Glens Falls Technical ParkGlens Falls, NY 12801 |
| Name ofPredicateDevices | Contour® Emboli PVAEmbosphere MicrospheresEmboGold Microspehers |
| Classification | Class III, 21 CFR 882.5950Submitted Per 21 CFR 807 |
| PerformanceStandards | Performance Standards have not been established by FDA under Section 514of the Food, Drug and Cosmetic Act |
| Intended Useand DeviceDescription | Contour SETM Microspheres are indicated for use for the embolization ofhypervascular tumors and arteriovenous malformations. |
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The Contour SETM Microspheres have been tested for biocompatibility per Biocompatibility ISO 10993. All data demonstrate this device is biocompatible for its intended use.
The Contour SE™ Microspheres have been tested and compared to the Summary of Substantial predicate device. All data gathered demonstrate this device as substantially Equivalence equivalent. No new issues of safety or efficacy have been raised.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 3 2003
Ms. Jodi Lynn Greenizen Regulatory Affairs Project Manager Boston Scientific Corporation Miami Technology Center 8600 N.W. 41 Street Miami, Florida 33166
Re: K032707
Trade/Device Name: Contour SETM Microspheres (Syringe) Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial Embolization Device Regulatory Class: III Product Code: HCG Dated: August 29, 2003 Received: September 2, 2003
Dear: Ms. Greenizen:
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.
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.
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Page 2 - Ms. Jodi Lynn Greenizen
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
| K032707 | |
|---|---|
| 510(k)Number(if known) | Unknown |
| Device Name: | Contour SET TM Microspheres |
| Indicationsfor Use | Contour SET TM Microspheres are indicated for use for the embolization ofhypervascular tumors and arteriovenous malformations. |
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K032707
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use (Optional Format 1-2-96)
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).