(28 days)
Contour SET ™ Microspheres are indicated for use for the embolization of hypervascular tumors and arteriovenous malformations.
Contour SET ™ Microspheres
The provided document is a 510(k) summary for the Contour SE™ Microspheres. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about specific acceptance criteria, device performance studies, or clinical (or human-related) effectiveness data.
Therefore, I cannot fulfill your request for the following sections based on the provided text:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document primarily focuses on demonstrating substantial equivalence through non-clinical means (biocompatibility testing and comparison to predicate devices). The relevant information from the document is related to the substantial equivalence claim, not specific performance study results meeting acceptance criteria in the way you've described.
Here's what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance
Not provided in the document. The document states: "All data demonstrate this device is biocompatible for its intended use" and "All data gathered demonstrate this device as substantially equivalent." These are general statements of compliance, not specific performance metrics against acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided. The document mentions "All data" but does not specify sample sizes for any test sets, nor provenance.
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 no human-read test sets or ground truth establishment by experts are described for performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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. The device (microspheres for embolization) is a medical implant, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance in the described manner.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document refers to biocompatibility testing (per ISO 10993) and comparison to predicate devices, implying that "ground truth" for substantial equivalence would be based on established standards, predicate device characteristics, and the results of the biocompatibility tests (e.g., cytotoxicity, sensitization, irritation indices). No clinical ground truth based on patient outcomes or expert consensus is mentioned for performance criteria.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device requiring a training set in that context.
9. How the ground truth for the training set was established
Not applicable.
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Special 510(k)
Contour SE™ Microspheres
July 24, 2002
Summary of Safety and Effectiveness
AUG 2 2 2 2002
| GeneralProvisions | Trade Name: Contour SET ™ Microspheres |
|---|---|
| Classification Name: Artificial Embolization Device | |
| Name ofPredicateDevices | Contour ® Emboli PVAEmbosphere MicrospheresEmboGold Microspehers |
| Classification | Class II |
| PerformanceStandards | Performance Standards have not been established by FDA under Section 514of the Food, Drug and Cosmetic Act |
| Intended Useand DeviceDescription | Contour SET ™ Microspheres are indicated for use for the embolization ofhypervascular tumors and arteriovenous malformations. |
| Biocompatibility | The Contour SET ™ Microspheres have been tested for biocompatibility perISO 10993. All data demonstrate this device is biocompatible for its intendeduse. |
| Summary ofSubstantialEquivalence | The Contour SET ™ Microspheres have been tested and compared to thepredicate device. All data gathered demonstrate this device as substantiallyequivalent. No new issues of safety or efficacy have been raised. |
0048
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three abstract shapes that resemble human profiles or stylized wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2002
Jodi Lynn Greenizen Regulatory Affairs Project Manager Boston Scientific Corporation 10 Glens Falls Technical Park Dix Avenue Glens Falls, New York 12801-3864
Re: K022427
Trade/Device Name: Contour SE™ Microspheres Regulation Number: 882.5950 Regulation Name: Artificial embolization devices Regulatory Class: Class III Product Code: HCG Dated: July 24, 2002 Received: July 25, 2002
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of vour 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
for Mark N. Melkers
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
| 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. |
(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)
Confidential
Boston Scientific Corporation
OR
Over-The Counter Use
(Optional Format 1-2-96)
for Mark N. Mekerson
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number. K022427
§ 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).