(90 days)
Not Found
No
The device description focuses on the physical properties and composition of the microspheres, and there is no mention of AI, ML, or any software-driven analytical or decision-making components. The device is a physical embolic agent.
Yes.
The device is intended to block blood flow to target tissues (hypervascular tumors and arteriovenous malformations), which constitutes a therapeutic action.
No
Explanation: The device is an embolic agent designed to block blood flow, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical product (microspheres) intended for embolization, not a software application.
Based on the provided information, the GelSpheres™ Embolic Agent is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the embolization of hypervascular tumors and arteriovenous malformations. This is a therapeutic procedure performed in vivo (within the body) to block blood flow.
- Device Description: The description details a physical material (microspheres) that is delivered into the body to achieve a physical effect (occlusion of arteries).
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The GelSpheres™ Embolic Agent does not perform this function. It is a therapeutic device used directly on the patient's vascular system.
Therefore, the GelSpheres™ Embolic Agent is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
"GelSpheres™ Embolic Agent is intended for embolization of hypervascular tumors and arteriovenous malformations."
Product codes (comma separated list FDA assigned to the subject device)
HCG, KRD
Device Description
GelSpheres™ Embolic Agent are preformed soft, deformable microspheres that occlude arteries for the purpose of blocking the blood flow to a target tissue, such as a hypervascualr tumor or arteriovenous malformations (AVM's). GelSpheres™ Embolic Agent consists of a macromer derived from polyvinyl alcohol (PVA). The fully polymerized microsphere is approximately 90% water and is compressible to approximately 20-30% by diameter. GelSpheres™ Embolic Agent is dyed blue to aid in the visualization of the microspheres in the delivery syringe. The microspheres can be delivered through typical microcatheters in the 1.8-5Fr range.
The product is supplied sterile and packaged in sealed glass bottles for V-Series Model numbers, and in pre-filled syringes for S- Series model numbers. Two quantities will be available in a vial: (1) 1.0 mL GelSpheres™ Embolic Agent in sterile physiologic buffered saline (PBS) to a volume of 8 mL. and (2) 2.0mL GelSpheres™ Embolic Agent in sterile PBS to a volume of 8 mL. Two quantities will be available in a pre-filled syringe: (1) 1.0mL GelSpheres™ Embolic Agent in sterile PBS to a volume of 5 mL, and (2) 2.0mL GelSpheres™ Embolic Agent in sterile PBS to a volume of 5 mL.
GelSpheres™ Embolic Agent is supplied in several units covering the range from 100um to 1200um diameter. The product size ranges are listed below:
| Size Range | 1 ML Vial
(7-11) | 2 ML Vial
(7-11) | 1 ML Syringe
(7-1) | 2 ML Syringe
(7-1) |
|------------|---------------------|---------------------|-----------------------|-----------------------|
| 100-300μm | V210GS | V220GS | S210GS | S220GS |
| 300-500μm | V410GS | V420GS | S410GS | S420GS |
| 500-700μm | V610GS | V620GS | S610GS | S620GS |
| 700-900μm | V810GS | V820GS | S810GS | S820GS |
| 900-1200μm | V1010GS | V1020GS | S1010GS | S1020GS |
At the time of use, GelSpheres™ Embolic Agent is mixed with a nonionic contrast agent, e.g. Omnipaque, to make a 30-50% by weight solution. The bolus of contrast agent elutes from the vascular bed to leave a radiolucent, embolized vessel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hypervascular tumors and arteriovenous malformations (AVM's)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
K02 3089
Original 510(k) Pre-Market Notification GelSpheres™ Embolic Agent
510(k) Summary
DEC 1 6 2002
September 13, 2002
Submitter: BioCure, Inc 2975 Gateway Drive Suite 100 Norcross, GA (678) 966-3422
Contact: Dennis Goupil. PhD
510(k) Numbers and Product Codes of equivalent devices.
Biosphere Medical, Inc.
Embospheres® Microspheres 510K Number: #K991549 Product Code: HCG CFR Section: 882.5950
Biosphere Medical, Inc.
EmboGold™ Microspheres 510K Number: #K010026 Product Code: HCG CFR Section: 882.5950
Indications for Use and Intended Population
GelSpheres™ Embolic Agent are indicated for Embolization of hypervascular tumors and arteriovenous malformations (AVM's)
Device Description
GelSpheres™ Embolic Agent are preformed soft, deformable microspheres that occlude arteries for the purpose of blocking the blood flow to a target tissue, such as a hypervascualr tumor or arteriovenous malformations (AVM's). GelSpheres™ Embolic Agent consists of a macromer derived from polyvinyl alcohol (PVA). The fully polymerized microsphere is approximately 90% water and is compressible to approximately 20-30% by diameter. GelSpheres™ Embolic Agent is dyed blue to aid in the visualization of the microspheres in the delivery syringe. The microspheres can be delivered through typical microcatheters in the 1.8-5Fr range.
1
The product is supplied sterile and packaged in sealed glass bottles for V-Series Model numbers, and in pre-filled syringes for S- Series model numbers. Two quantities will be available in a vial: (1) 1.0 mL GelSpheres™ Embolic Agent in sterile physiologic buffered saline (PBS) to a volume of 8 mL. and (2) 2.0mL GelSpheres™ Embolic Agent in sterile PBS to a volume of 8 mL. Two quantities will be available in a pre-filled syringe: (1) 1.0mL GelSpheres™ Embolic Agent in sterile PBS to a volume of 5 mL, and (2) 2.0mL GelSpheres™ Embolic Agent in sterile PBS to a volume of 5 mL.
GelSpheres™ Embolic Agent is supplied in several units covering the range from 100um to 1200um diameter. The product size ranges are listed below:
| Size Range | 1 ML Vial
(7-11) | 2 ML Vial
(7-11) | 1 ML Syringe
(7-1) | 2 ML Syringe
(7-1) |
|------------|---------------------|---------------------|-----------------------|-----------------------|
| 100-300μm | V210GS | V220GS | S210GS | S220GS |
| 300-500μm | V410GS | V420GS | S410GS | S420GS |
| 500-700μm | V610GS | V620GS | S610GS | S620GS |
| 700-900μm | V810GS | V820GS | S810GS | S820GS |
| 900-1200μm | V1010GS | V1020GS | S1010GS | S1020GS |
At the time of use, GelSpheres™ Embolic Agent is mixed with a nonionic contrast agent, e.g. Omnipaque, to make a 30-50% by weight solution. The bolus of contrast agent elutes from the vascular bed to leave a radiolucent, embolized vessel.
Similarities and Differences to Predicates
The Intended Use of GelSpheres™ Embolic Agent and the predicate devices is the same. All devices are intended to be delivered to selected sites through catheters with a diameter appropriate for the vascular target and the size of the emboli. Accurate placement of all of the embolization devices is assured through visualization of the embolization process using radiographic imaging. All of the devices are mixed with a radiopacity agent prior to iniection to permit visualization. GelSpheres™ Embolic Agent, like the predicate devices are available in a range of sizes to permit selection of the most appropriate size for target vessels. GelSpheres™ Embolic Agent are made from polyvinyl alcohol, whereas Embospheres® Microspheres and EmboGold™ Microspheres are comprised of acrylic polymer impregnated with gelatin. GelSpheres™ Embolic Agent and Embospheres® Microspheres are deformable microspheres. GelSpheres™ Embolic Agent and EmboGold™ microspheres are colored to make the device more visible to the physician when preparing and injecting the embolic agents in a syringe. GelSpheres™ Embolic Agent and the substantially equivalent
2
devices are intended for single use and are supplied sterile and non pyrogenic. GelSpheres™ Embolic Agent , Embospheres™ Microspheres and EmboGold™ are all supplied in both bottles and syringes.
There are more similarities than differences when comparing BioCure, GelSpheres™ to the predicate devices.
Performance Standards
The BioCure GelSpheres™ Embolic Agent meets the following Performance Standards:
- Guidance For Industry: 2000: FDA Guidance for Neurological . Embolization Products
- ISO/EN 10993-1; 1997 Biological Evaluation of Medical Devices, ● Part I: Evaluation and Testing
- ISO/EN 10993-3; 1993 Biological Evaluation of Medical Devices, . Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
- ISO/EN 10993-4: 1993 Biological Evaluation of Medical Devices, . Part 4: Selection of tests for interaction with blood.
- . ISO/EN 10993-6; 1995 Biological Evaluation of Medical Devices, Part 6: Test for local effects after implantation.
- ISO/EN 10993-10: 1995 Biological Evaluation of Medical Devices, . Part 10: Tests for Irritation and Sensitization.
- . ISO/EN 10993-11; 1993 Biological Evaluation of Medical Devices, Part 11: Tests for Systemic Toxicity.
- ISO/EN 10993-13: 1995 Biological Evaluation of Medical Devices, . Part 13: Identification and Quantification of potential degradation products from polymers.
- ISO/EN 11607; 1997 Packaging for terminally sterilized products. .
- AAMI TIR 22;1998 -- Guidance for application of EN 11607, . Packaging for terminally sterilized products
- . AAMI 11134; 1993 - Sterilization of Health Care Products -Requirements for validation and routine control - Industrial moist heat sterilization 2nd edition.
- . ANSI/AAMI/ISO 14937; 2000 - Sterilization of Health Care Products - Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices.
3
- EN 554: Sterilization of Medical Devices validation and Routine . Control of Sterilization by Moist Heat
Conclusion
There are more similarities than differences between the predicate devices and the BioCure, Inc. GelSpheres™ Embolic Agent. Both the predicate devices and GelSpheres™ have the same intended use, warnings and contraindications. Both the predicate devices and GelSpheres are similar in design. When used in accordance with the instructions for use, by qualified personnel, the BioCure, Inc. GelSpheres™ are safe and effective, as indicated, for the intended use.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/4/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN" around the top half and what appears to be "SERVICES" around the bottom half. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 6 2007
BioCure, Inc. c/o Mr. John Greenbaum Generic Devices Consulting, Inc. 20310 SW 48th Street Fort Lauderdale, Florida, 33332
Re: K023089
Trade/Device Name: GelSpheres Embolic Agent Regulation Number: 21 CFR 882,5950; 21 CFR 870,3300 Regulation Name: Artificial embolization device; Arterial Embolization Device Regulatory Class: III Product Code: HCG; KRD Dated: September 13, 2002 Received: September 17, 2002
Dear Mr. Greenbaum:
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. 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.
5
Page 2 - Mr. John Greenbaum
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. 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" (21CFR 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,
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
6
KOZ 3089
000008
Page 1 of 1
510(k) Number(if known):_
Device Name: GelSpheres™ Embolic Agent
Indications For Use:
"GelSpheres™ Embolic Agent is intended for embolization of hypervascular 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_X_
| (Per 21 CRF 801.109) | OR | Over-The-Counter Use_ |
|---|---|---|
| --------------------------------------------- | ---- | ----------------------- |
(Optional Format 1-2-96)
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K023089 |
|---|---|
| --------------- | --------- |