(42 days)
Not Found
No
The device description and performance studies focus on the material properties and delivery mechanism of the embolic agent, with no mention of AI or ML.
Yes
The device is used to treat conditions such as hypervascular tumors and bleeding by occluding blood flow, which are therapeutic interventions.
No
Explanation: The OBSIDIO™ Conformable Embolic is an embolic agent used to occlude blood flow, which is a therapeutic rather than a diagnostic function. It is used to treat conditions like hypervascular tumors and bleeding, not to diagnose them.
No
The device description clearly states it is a premixed embolic agent consisting of physical materials (gelatin, layered silicate, tantalum powder) delivered via a syringe and microcatheter. This is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the embolization of hypervascular tumors and blood vessels to control bleeding/hemorrhaging in the peripheral vasculature. This is a therapeutic procedure performed within the body to treat a condition.
- Device Description: The device is an embolic agent delivered directly into blood vessels. It is a physical material used to block blood flow.
- Lack of Diagnostic Function: There is no mention of this device being used to diagnose a condition, analyze samples (blood, tissue, etc.) in vitro (outside the body), or provide information for diagnostic purposes.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The OBSIDIO™ Conformable Embolic is indicated for use in the embolization of:
- Hypervascular tumors
- . Blood vessels to occlude blood flow for controlling bleeding/hemorrhaging in the peripheral vasculature
Product codes
KRD
Device Description
The OBSIDIO™ Conformable Embolic is a premixed embolic agent consisting of pre-hydrated gelatin and layered silicate, and tantalum powder (to provide for visualization under fluoroscopy). Obsidio Embolic is delivered directly through a microcatheter into the blood flow to target tissue without relying on precipitation or polymerization. The material conforms to the shape of the vessel. Obsidio Embolic is packaged in a 1 mL (1 cc) syringe. The device is supplied as a sterile, single use product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Use characterization analysis was used to support labeling updates with added use instructions and warnings to enhance safe and effective use of the subject OBSIDIO™ Conformable Embolic. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or effectiveness issues were raised during the device testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
October 3, 2024
Boston Scientific Heidi Shearer Regulatory Affairs Specialist 1 Scimed Place Maple Grove, Minnesota 55311
Re: K242507
Trade/Device Name: OBSIDIO™ Conformable Embolic Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: August 22, 2024 Received: September 24, 2024
Dear Heidi Shearer:
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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advice-comprehensiveregulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Finn E. Finn E. Donaldson -S Donaldson -S Date: 2024.10.03 16:05:24 -04'00'
Finn Donaldson Assistant Director (acting) DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K242507
Device Name Obsidio Conformable Embolic
Indications for Use (Describe)
Obsidio Conformable Embolic is indicated for use in the embolization of:
- · Hypervascular tumors,
· Blood vessels to occlude blood flow for controlling bleeding/hemorrhaging in the peripheral vasculature.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
text
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510(k) Summary
510(K) Summary Complying with 21 CFR 807.92
I. SUBMITTER INFORMATION
Submitter Name: Boston Scientific Corporation
Submitter Address:
One Scimed Place Maple Grove, MN 55311-1566 USA
Telephone: 763-255-0056 e-mail: Heidi.Shearer@bsci.com Contact person name: Heidi Shearer
Date Prepared: August 22, 2024
II. DEVICE INFORMATION
OBSIDIO™ Conformable Embolic, UPN M0013972101010
Table 1: Device Information
| Common or
Usual name | Regulatory
Number | Regulatory
Name | Product Code | Product Code
Name | Regulatory
Class |
|------------------------------------|-------------------------|------------------------------------|--------------|-------------------------------------------------------|---------------------|
| Vascular
embolization
device | 21 CFR Part
870.3300 | Vascular
Embolization
Device | KRD | Device,
Vascular, For
Promoting
Embolization | II |
III. PREDICATE DEVICE IDENTIFICATION
Name of Predicate Device
OBSIDIO™ Conformable Embolic (K213385, Cleared July 1, 2022)
IV. DEVICE DESCRIPTION
The OBSIDIO™ Conformable Embolic is a premixed embolic agent consisting of pre-hydrated gelatin and layered silicate, and tantalum powder (to provide for visualization under fluoroscopy). Obsidio Embolic is delivered directly through a microcatheter into the blood flow to target tissue without relying on precipitation or polymerization. The material conforms to the shape of the vessel. Obsidio Embolic is packaged in a 1 mL (1 cc) syringe. The device is supplied as a sterile, single use product.
V. INDICATIONS FOR USE
Predicate and subject device intended use / indications for use are the same.
Intended Use / Indications for Use
The OBSIDIO™ Conformable Embolic is indicated for use in the embolization of:
- Hypervascular tumors
- . Blood vessels to occlude blood flow for controlling bleeding/hemorrhaging in the peripheral vasculature
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The subject and predicate OBSIDIO™ Conformable Embolic have the same technical characteristics. The device is an implantable peripheral vascular embolization device composed of pre-hydrated gelatin, layered silicate, tantalum, and water. The material is contained in a 1 mL syringe and supplied as a sterile, single use product within one sterile barrier peelable pouch per shelf carton.
VII. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING
Use characterization analysis was used to support labeling updates with added use instructions and warnings to enhance safe and effective use of the subject OBSIDIO™ Conformable Embolic. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or effectiveness issues were raised during the device testing.
VIII. CONCLUSION
This 510(k) was submitted to implement labeling updates as part of mitigations for a recent Class I Recall. Based on the intended use, technological characteristics, and the use characterization analysis data provided, the subject OBSIDIO™ Conformable Embolic with proposed labeling updates is substantially equivalent to the predicate OBSIDIO™ Conformable Embolic device (K213385).