Embosphere® and EmboGold™ Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including and uterine fibroids.

Embosphere Microspheres are indicated for use in embolization of arteriovenous malformations, hypervascular turnors, and symptomatic uterine fibroids.

Device Description

Embosphere® and EmboGold™ Microspheres are small, flexible, hydrophilic, biocompatible spheres made of acrylic polymer and porcine-derived gelatin. The microspheres are packaged in 0.9% saline and are provided sterile and nonpyrogenic. They are delivered to the target site by a catheter under fluoroscopic control.

Both products are provided in six size ranges in order to allow physicians to choose the calibration necessary for the vessel being embolized. The size ranges available are:

40-120 microns
100-300 microns
300-500 microns
500-700 microns
700-900 microns
900-1200 microns

Only microspheres of 500 microns or greater should be used for the embolization of uterine fibroids.

The only difference between Embosphere® and EmboGold™ Microspheres is the colorization of the EmboGold™ Microspheres. Embosphere® Microspheres are translucent, although they are visible to the naked eye when in suspension. EmboGold™ Microspheres are purple/red in color for improved visibility during preparation and handling by the physician.

AI/ML Overview

The provided text describes the 510(k) submission for Embosphere® Microspheres and EmboGold™ Microspheres for use in Uterine Fibroid Embolization. Since this is an embolization device and not a diagnostic AI device, many of the requested criteria (e.g., acceptance criteria for diagnostic performance, sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from the provided text.

However, I can extract information related to the clinical study performed to support the device's safety and effectiveness for its intended use in uterine fibroid embolization.

Acceptance Criteria and Device Performance (Not directly applicable as this is not a diagnostic device with performance metrics like sensitivity/specificity):

The acceptance criteria for this type of device typically revolve around demonstrating safety and effectiveness for the intended use, often compared to an existing predicate device. The text states: "Clinical data was collected in a prospective clinical study to support the safety and effectiveness of Embosphere® Microspheres for uterine fibroid embolization." Specific quantitative acceptance criteria or detailed device performance metrics (e.g., success rates, complication rates, fibroid reduction) are not provided in this 510(k) summary.

Study Type and Design:

Study Name: Not explicitly named, but referred to as a "prospective clinical study."
Purpose: To support the safety and effectiveness of Embosphere® Microspheres for uterine fibroid embolization.

Missing Information (and why it's missing from this type of document):

Many of the questions are geared towards diagnostic AI models, which have different evaluation methodologies than medical devices like embolization microspheres. Therefore, much of the requested information cannot be found in this 510(k) summary for a medical device.

Here's a breakdown of the requested information based on the provided text, and an explanation for the missing parts:

Acceptance Criteria and Device Performance

Acceptance Criteria (Inferred from 510(k) process)	Reported Device Performance (Not explicitly detailed in this summary)
Safety for Uterine Fibroid Embolization	Clinical data supported safety (specific metrics not provided)
Effectiveness for Uterine Fibroid Embolization	Clinical data supported effectiveness (specific metrics not provided)
Substantial Equivalence to Predicate Devices	Deemed substantially equivalent by FDA

Detailed Study Information

Sample Size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: "Clinical data was collected in a prospective clinical study". The country of origin is not specified but is implicitly within the scope of FDA approval requirements, likely U.S. or international studies following regulatory guidelines.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a therapeutic device like embolization microspheres, "ground truth" as it applies to diagnostic image interpretation by experts is not a relevant concept. The "truth" would be clinical outcomes (e.g., fibroid reduction, symptom improvement), not interpretations of images.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 are used for resolving discrepancies in expert interpretations of images or data, which is not relevant for evaluating the performance of an embolization device in a clinical study.
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 a diagnostic AI device, so MRMC studies involving human readers and AI assistance are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not a standalone algorithm. Its performance inherently involves human intervention (physician delivery).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Clinical Outcomes Data. While not explicitly stated with detail, for a device used to treat uterine fibroids, the "ground truth" for effectiveness would be based on measured clinical outcomes such as reduction in fibroid volume, improvement in symptoms, and patient quality of life, alongside safety parameters.
The sample size for the training set:
- Not Applicable. As a medical device rather than a machine learning model, there is no "training set" in the AI sense. Performance is established through preclinical testing and clinical studies.
How the ground truth for the training set was established:
- Not Applicable. See point 7.

Summary

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K021397

510(k) Summary

for

Embosphere® Microspheres and EmboGold™ Microspheres for use in Uterine Fibroid Embolization

1. SPONSOR
  Biosphere Medial, Inc. 1050 Hingham Street Rockland, MA 02370

Contact Person: Jon McGrath, Vice President of Research Telephone: 781-681-7950

Date Prepared: April 30, 2002

2. DEVICE NAME

Proprietary Name:	Embosphere® Microspheres and EmboGold™Microspheres for use in Uterine Fibroid Embolization
Common/Usual Name:	Artificial emboli
Classification Name:	Artificial Embolization Device (21 CFR 882.5950 and21 CFR 870 3300)

3. PREDICATE DEVICES

Embosphere® Microspheres as reviewed under K991549 and EmboGold™ Microspheres as reviewed under K010026.

4. INTENDED USE

Embosphere® and EmboGold™ Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including and uterine fibroids.

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5. DEVICE DESCRIPTION

Both products are provided in six size ranges in order to allow physicians to choose the calibration necessary for the vessel being embolized. The size ranges available are:

40-120 microns 100-300 microns 300-500 microns 500-700 microns 700-900 microns 900-1200 microns
Only microspheres of 500 microns or greater should be used for the embolization of uterine fibroids.

6. BASIS FOR SUBSTANTIAL EQUIVALENCE

Embosphere® and EmboGold™ Microspheres for uterine fibroid embolization are substantially equivalent to the same products when indicated for the more general intended use of embolization of hypervascular tumors. Clinical data was collected in a prospective clinical study to support the safety and effectiveness of Embosphere® Microspheres for uterine fibroid embolization. EmboGold™ Microspheres are the same product as Embosphere® Microspheres, except for the colorization. Data to support the substantial equivalence of EmboGold™ Microspheres to Embosphere® Microspheres was previously provided in K010026.

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od and Drug Administration 00 Corporate Boulevard Rockville MD 20850

NOV 22 2002

BioSphere Medical, Inc. % Sheila Hemeon-Heyer, J.D., R.A.C. Senior Staff Consultant Medical Device Consultants 49 Plain Street NORTH ATTLEBORO MA 02760

Re: K021397 Trade/Device Name: Embosphere® Microspheres for UFE. Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial Embolization device Regulatory Class: III Product Code: 85 NAJ Dated: August 27, 2002 Received: August 28, 2002

Dear Ms. Hemeon-Heyer:

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 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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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 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,

Henry C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Embosphere® Microspheres for use in Device Name: Uterine Fibroid Embolization

Indications for Use:

Embosphere Microspheres are indicated for use in embolization of arteriovenous malformations, hypervascular turnors, and symptomatic uterine fibroids.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Beardon

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use __________

(Optional Format 1-2-96

Embosphere Microspheres & EmboGold Additional Information - K021397

August 27, 2002 CONFIDENTIAL Appendix E · Page 1

Regulation Number and Section

§ 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).