(72 days)
The Concentric Embolic Pearls are intended for use in the embolization of hypervascularized tumors in the peripheral vasculature.
The Concentric Embolic Pearls are non-resorbable, hydrogel-based spherical microbeads. The Embolic Pearls are delivered via a catheter in an amount and size appropriate for the targeted area. The Embolic Pearls slow/stop blood flow to hypervascularized tumors by occluding the blood vessel which provides blood flow to the tumor.
The provided text describes the Concentric Embolic Pearls, an arterial embolization device, and its successful clearance via a 510(k) pathway. However, it does not contain a detailed study with specific acceptance criteria, reported device performance metrics, or information on reader studies, training/test set sizes, or ground truth establishment in the way typically seen for AI/ML-based devices.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through various testing summaries. Therefore, I will create a table representing the stated equivalence, and then address the other points based on the information provided in the document, noting where information is absent.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)
The document states that the Concentric Embolic Pearls are "substantially equivalent to the existing legally marketed predicate devices" and that all characteristics/attributes are "either identical or substantially equivalent." The acceptance criteria, therefore, are implicitly the performance and safety characteristics demonstrated by the predicate devices.
| Acceptance Criteria Category | Reported Device Performance (Concentric Embolic Pearls) |
|---|---|
| Performance & Functional | "Successfully passed all performance and functional testing performed demonstrating that the device performs in accordance with the requirements of the Product Specification." |
| Material/Chemical Safety | "No harmful levels of residuals, monomers, or leachables are detectable." |
| Biocompatibility | "Substantially equivalent to the negative control article and no significant adverse reactions were noted." |
| In-vivo Delivery | "Consistent delivery of the Embolic Pearls to the treatment site." |
| In-vivo Safety (Vessel Damage) | "No vessel damage occurs when the Embolic Pearls are deployed to the treatment site." |
| In-vivo Performance (Comparison to Predicate) | "Performed similarly to the EmboGold Microspheres." |
| Intended Use | "Embolization of hypervascularized tumors in the peripheral vasculature." (Matches predicate's general use) |
Study Details:
Given the nature of the device (a physical medical device, not an AI/ML algorithm), many of the requested categories are not applicable or not detailed in this type of 510(k) summary. I will address each point based on the provided text:
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A table of acceptance criteria and the reported device performance: (See table above). The acceptance criteria are largely implied by successful completion of various tests showing equivalence to predicate devices and meeting product specifications.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size (In-vivo animal testing): Not explicitly stated. The document mentions "in-vivo animal testing performed" but does not quantify the number of animals or trials.
- Data Provenance: Not specified. Animal testing is implied, and could be internal R&D. The country of origin is not mentioned. It would be prospective in nature for these tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this device type and the reported testing. Ground truth for a physical embolic device typically involves objective measurements (e.g., in-vitro flow testing, material analysis) and expert observation/assessment during animal studies (e.g., by veterinarians, pathologists, interventional specialists), but the number and qualifications are not specified here.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not a reader study for image interpretation.
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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:
- No MRMC study was done. This is not an AI-assisted 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 algorithm-only device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For material and chemical safety: Analytical chemistry results, biocompatibility studies (e.g., cytotoxicity tests, sensitization, irritation indices).
- For functional performance: In-vitro bench testing against engineering specifications (e.g., flow rates, delivery consistency).
- For in-vivo performance and safety: Observations during animal studies, potentially histopathological examination of tissues, imaging results (e.g., angiography) to assess delivery and vessel damage.
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The sample size for the training set:
- Not applicable. This is not a machine learning device that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable.
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MAY - 6 2005
510(k) Summary
| General InformationClassification | Class II, Arterial Embolization Device per 21 CFR § 870.3300 |
|---|---|
| Trade Name | Concentric Embolic PearlsTM |
| Submitter | Concentric Medical, Inc.1380 Shorebird WayMountain View, CA 94043tel: 650-938-2100 |
| Contact | Jean M. Caillouette, RACManager, Regulatory Affairs |
Intended Use
The Concentric Embolic Pearls are intended for use in the embolization of hypervascularized tumors in the peripheral vasculature.
| Predicate Devices | |
|---|---|
| EMBOSPHERE® Microspheres | K991549 |
| Manufactured by Biosphere Medical, Inc. |
EmboGold™ Microspheres K010026 Manufactured by Biosphere Medical, Inc.
K951314, K965174 TruFilI™ PVA Particles Manufactured by Cordis Endovascular Systems
Device Description
The Concentric Embolic Pearls are non-resorbable, hydrogel-based spherical microbeads. The Embolic Pearls are delivered via a catheter in an amount and size appropriate for the targeted area. The Embolic Pearls slow/stop blood flow to hypervascularized tumors by occluding the blood vessel which provides blood flow to the tumor.
Materials
All materials used in the manufacture of the Concentric Embolic Pearls are suitable for the intended use of the device.
Testing Summary
The Concentric Embolic Pearls have successfully passed all performance and functional testing performed demonstrating that the device performs in accordance with the requirements of the Product Specification. In all biocompatibility studies performed, the results for the Concentric Embolic Pearls was substantially equivalent to the negative control article and no significant adverse reactions were noted in any study conducted. Results of chemical assays performed clearly demonstrate that no harmful levels of
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residuals, monomers, or leachables are detectable in the Concentric Embolic Pearls following hydration. Results of in-vivo animal testing performed demonstrated consistent delivery of the Embolic Pearls to the treatment site, that no vessel damage occurs when the Embolic Pearls are deployed to the treatment site, and overall, the Embolic Pearls performed similarly to the EmboGold Microspheres.
Summary of Substantial Equivalence
All characteristics/attributes of the Concentric Embolic Pearls are either identical or substantially equivalent to the existing legally marketed predicate devices identified in this application. As such, Concentric Medical, Inc. believes the Concentric Embolic Pearls are substantially equivalent to the legally marketed predicate devices.
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular pattern around the symbol. The caduceus symbol is black, and the text is also black.
MAY - 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Concentric Medical, Inc. c/o Ms. Jean M. Caillouette, RAC 1380 Shorebird Way Mountain View, CA 94043
Re: K050470
Trade Name: Embolic Pearls Regulation Number: 21 CFR 870.3300 Regulation Name: Arterial embolization device Regulatory Class: II (two) Product Code: KRD Dated: February 18, 2005 Received: February 23, 2005
Dear Ms. Caillouette:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your becally is release is substantially equivalent (for the indications felerenced above and nave determined the arredicate devices marketed in interstate for use stated in the encrosule) to regard cate of the Medical Device Amendments, or to commerce prior to May 20, 1978, the ensordance with the provisions of the Federal Food. Drug. devices mail have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, merciole, market the device, books of the more of the manual registration, listing of general controls provisions of the tice, 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 If your device is classified (seculory) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations EDA may be subject to sach additional controlior "Entoung thing to the 898. In addition, FDA may be found in the Outs acements concerning your device in the Federal Register.
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Page 2 - Ms. Jean M. Caillouette, RAC
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Toase oc advisou that I Dr Unstan that your device complies with other requirements of the Act that I DA has made a decemmandis as administered by other Federal agencies. You must or any I cuttar suttates and regulations including, but not limited to: registration and listing (21 comply with an the 7te 31equirements, 01); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quarty bybellio (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation contact pro revious marketing your device as described in your Section 510(k) I mis letter will unon you to cognifiating of substantial equivalence of your device to a legally promatics notification: "The Pressification 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 If you desire specific aarroliance at (240) 276-0120. Also, please note the regulation entitled, Condor the Office of Court Court Cation" (21CFR Part 807.97). You may obtain Whisoranuing of Tereferee to presessonsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Dma R. Vachner
Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Concentric Medical, Inc. Concentric Embolic Pearls™
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
K650470 This application
Concentric Embolic Pearls™
ﺒ
The Concentric Embolic Pearls™ are indicated for use in the embolization of hypervascularized tumors in the peripheral vasculature.
Prescription Use X_OR
Over-The-Counter Use -------
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Durich K. 16 C (Division Sin .:- Off)
Division of Cardiovascular Devices
510(K) Number_K050470
Confidential
Page 9 of 79
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(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 § 870.1(e).