(25 days)
ONCOZENE™ Microspheres are intended for embolization of hypervascular tumors and arteriovenous malformations.
ONCOZENE™ Microspheres are indicated for the embolization of hypervascular tumors and arteriovenous malformations.
ONCOZENE™ Microspheres are precise dimensioned, soft, deformable microspheres intended to occlude vasculature for the purpose of blocking blood flow to a target tissue such as hypervascular tumor (HVT) or arteriovenous malformation (AVM). ONCOZENE™ Microspheres are manufactured from sodium polymethacrylate and coated with proprietary Polyzene®-F. The fully polymerized microspheres are compressible to enable smooth delivery through the indicated delivery catheter. ONCOZENE™ Microspheres contain no added dyes and are visually opaque. ONCOZENE™ Microspheres are supplied sterile and packaged in 20ml polycycloolefin syringes with a standard 7ml fill volume across the range. Available as 40μm, 75μm and 100μm microsphere diameter sizes, the ONCOZENE™ syringes are available with 2ml or 3ml microsphere volume per syringe.
The provided text describes a 510(k) premarket notification for a medical device called ONCOZENE™ Microspheres. This submission is for demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a clinical study with an aim to assess algorithm performance. Therefore, many of the requested categories, such as "reported device performance," "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone algorithm performance," "type of ground truth," "sample size for training set," and "how ground truth for training set was established," are not directly applicable or available in this type of submission.
Instead, the submission focuses on demonstrating equivalence based on similar design, specifications, fundamental scientific technology, and performance established through in-vitro testing, literature review, and post-market surveillance of the predicate device.
Here's the information that can be extracted or inferred based on the nature of a 510(k) submission for this type of device:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate)
Since this is a 510(k) submission establishing substantial equivalence for a medical device that physically occludes vasculature, the "acceptance criteria" are not performance metrics of an AI algorithm, but rather a demonstration that the new device (ONCOZENE™ Microspheres) is as safe and effective as the predicate device (Embozene Microspheres). The "reported device performance" is essentially showing that ONCOZENE™ Microspheres meet or fall within the established specifications and safety profile demonstrated by the predicate.
| Acceptance Criteria Category | Reported ONCOZENE™ Device Performance (vs. Predicate) |
|---|---|
| Intended Use | Equivalent (embolization of hypervascular tumors and arteriovenous malformations). |
| Design | Same. |
| Specifications | Same for key characteristics like chemical composition, osmolarity, sterility, total fill volume, and shelf life. pH of transport solution is tighter for ONCOZENE™ but within existing specification cleared for the predicate. Available diameter sizes (40μm, 75μm, 100μm) are a subset of the predicate's sizes. |
| Fundamental Scientific Technology | Same (precise dimensioned, soft, deformable microspheres made from sodium polymethacrylate and coated with Polyzene®-F, intended to occlude vasculature). |
| Packaging | Similar (supplied sterile and packaged in polycycloolefin syringes). Microsphere volume per syringe is 2ml or 3ml for ONCOZENE™ compared to 1ml or 2ml for predicate. |
| Safety and Effectiveness | Concluded to be safe and effective based on: - Equivalence to predicate. - Extensive review of scientific literature (1029 abstracts) on Transarterial Embolization (TAE) with various embolic agents, including the predicate. - Review of CeloNova's adverse event data from >70,000 units of predicate distributed worldwide. |
1. A table of acceptance criteria and the reported device performance:
See table above. The "acceptance criteria" here refers to the parameters for demonstrating substantial equivalence. The "reported device performance" refers to how ONCOZENE™ Microspheres compare to these parameters and to the predicate device.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of a traditional "test set" for an AI algorithm. The evaluation relies on in-vitro testing of the ONCOZENE™ Microspheres and a broad review of clinical experience with the predicate device and similar embolic agents.
- Data Provenance: The "clinical experience" review involved:
- 1029 abstracts from a PubMed search.
- CeloNova's adverse event data resulting from over 70,000 units of the predicate device distributed worldwide.
- This data is retrospective, covering experience over the last ten years with Transarterial Embolization (TAE) using various embolic agents. The countries of origin for the PubMed abstracts and worldwide distribution would be global.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a medical device submission based on substantial equivalence, not an AI algorithm performance study requiring expert ground truthing. The "ground truth" concerning the safety and effectiveness of embolization with these types of microspheres is established through decades of medical practice, clinical trials (for the predicate and similar devices), and post-market surveillance summarized in the literature review.
4. Adjudication method for the test set:
Not applicable. No "test set" in the sense of a set of cases requiring adjudication for ground truth.
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. This device is a physical embolization microsphere, not an AI diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an AI algorithm. The device itself is "standalone" in that it performs its physical function (occlusion) without human-in-the-loop interaction during its mechanism of action, but its performance evaluation in this submission is not in the context of an algorithm.
7. The type of ground truth used:
For the conclusion of safety and effectiveness, the "ground truth" is based on:
- Expert Consensus/Clinical Evidence: Derived from a comprehensive literature review of Transarterial Embolization (TAE) using various embolic agents, including the predicate device, performed over the last ten years.
- Outcomes Data/Post-Market Surveillance: Adverse event data from over 70,000 units of the predicate device distributed worldwide.
- In-vitro Testing: Summary of in-vitro data for ONCOZENE™ Microspheres showing that minor manufacturing changes (for tighter pH control) did not necessitate additional testing.
8. The sample size for the training set:
Not applicable. There is no AI training set involved in this submission.
9. How the ground truth for the training set was established:
Not applicable. There is no AI training set involved in this submission.
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K 130307
MAR 0 4 2013
510(k) Summary of Safety and Effectiveness
| Summary Date: | February 5, 2013 |
|---|---|
| Submitter: | CeloNova BioSciences, Inc.18615 Tuscany StoneSan Antonio, TX 78258Fax: 210.497.6682Fax: 210.403.2008 |
| Contact : | Nicole C. BarberSr. Regulatory Specialist |
1. Common name, Trade name & Classification
Trade Name: ONCOZENE™ Microspheres Common Name & Codes: Vascular Embolization device, embolization, arterial (21CFR 870.3300, product code KRD)
2. 510(k) Number and Product code of predicate device
| Trade Name: | Embozene Microspheres |
|---|---|
| Manufacturer: | CeloNova BioSciences, Inc |
| 510(k) number: | K073417 |
| Product code : | KRD, 21 CFR 870.3300 |
3. Indications for Use and Intended Purpose
ONCOZENE™ Microspheres are intended for embolization of hypervascular tumors and arteriovenous malformations.
4. Device Description
ONCOZENE™ Microspheres are precise dimensioned, soft, deformable microspheres intended to occlude vasculature for the purpose of blocking blood flow to a target tissue such as hypervascular tumor (HVT) or arteriovenous malformation (AVM). ONCOZENE™ Microspheres are manufactured from sodium polymethacrylate and coated with proprietary Polyzene®-F. The fully polymerized microspheres are compressible to enable smooth delivery through the indicated delivery catheter. ONCOZENE™ Microspheres contain no added dyes and are visually opaque.
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510(k) Summary of Safety and Effectiveness (continued)
ONCOZENE™ Microspheres are supplied sterile and packaged in 20ml polycycloolefin syringes with a standard 7ml fill volume across the range. Available as 40μm, 75μm and 100μm microsphere diameter sizes, the ONCOZENE™ syringes are available with 2ml or 3ml microsphere volume per syringe. The product configurations are shown in the Table below.
| Product REF Codes | Volume of ONCOZENE™ Microspheres per syringe | ||
|---|---|---|---|
| 2ml microspheres | 3ml microspheres | ||
| ONCOZENE™Microspherediameter | 40 μm ±10 μm | 10420-US1 | 10430-US1 |
| 75 μm ±15 μm | 10720-US1 | 10730-US1 | |
| 100 μm ±25 μm | 11020-US1 | 11020-US1 |
5. Similarities and Differences to Predicate device
The intended use of ONCOZENE™ Microspheres and the predicate are equivalent. ONCOZENE™ Microspheres and the predicate device have the same design, specifications, fundamental scientific technology, and packaging.
The pH range of ONCOZENE™ Microspheres is more tightly controlled than the predicate but within the existing specification cleared for the predicate. Minor process changes have been made to achieve the tighter control of the pH range.
The predicate device is available in 1ml and 2ml microsphere volume per syringe. ONCOZENE™ Microspheres are available in 2ml and 3ml microsphere volume per syringe.
The predicate device is available sizes 40μm, 75μm, 400μm, 400μm, 500μm, 700μm, and 900μm. ONCOZENE™ Microspheres are available in sizes 40μm, 75μm, and 100μm.
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6. Summary of Technological Characteristics
| Point of Comparison | Predicate | ONCOZENE™ |
|---|---|---|
| Chemical composition | unchanged | unchanged |
| Osmolarity of transport solution | unchanged | unchanged |
| pH of transport solution | pH of transport solution is tighter for ONCOZENE than predicate but within existing specification for cleared predicate | pH of transport solution is tighter for ONCOZENE than predicate but within existing specification for cleared predicate |
| Size Range | $40 \pm 10 \mu m$$75 \pm 15 \mu m$$100 \pm 25 \mu m$$250 \pm 50 \mu m$$400 \pm 50 \mu m$$500 \pm 50 \mu m$$700 \pm 50 \mu m$$900 \pm 75 \mu m$ | $40 \pm 10 \mu m$$75 \pm 15 \mu m$$100 \pm 25 \mu m$ |
| Color Code | Color or opaque | Opaque |
| Sterility | Pyrogen-free, sterile | Pyrogen-free, sterile |
| Packaging | Syringe or vial | Syringe |
| Syringe total fill volume | 7ml | 7ml |
| Microsphere volume per syringe | 1 or 2 ml | 2 or 3 ml |
| Shelf life | unchanged | unchanged |
| Indication for Use | unchanged | unchanged |
Comparison between predicate (Embozene®) and ONCOZENE™Microspheres
7. Summary of In-Vitro Testing
The ONCOZENE™ Microspheres are a variant within the existing specification cleared for the predicate device. The minor changes made to the manufacturing processes to achieve tightened control of pH have not led to additional testing requirements.
8. Summary of Clinical Experience
The clinical evaluation included in the 510(k) reviews experience over the last ten years with Transrterial Embolization (TAE) using various embolic agents to physically occlude vessels to restrict blood flow. The evaluation looks at 1029 abstracts from the PubMed search including the predicate device and other embolic devices and reviews CeloNova's adverse event data resulting from in excess of 70,000 units distributed worldwide.
The overall review of the scientific literature and post market surveillance, indicate that embolization of tumors with small (40 µm and 100 µm) microspheres (Embozene® Microspheres) remain safe and effective for the treatment of hypervascularized tumors and arteriovenous malformations. Therefore, it could be concluded that the benefits of TAE with Embozene microspheres family including the
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510(k) Summary of Safety and Effectiveness (continued)
ONCOZENE™ Microspheres for the treatment of hypervascular tumors and arteriovenous malformations outweigh the potential risk when used within their labeled application.
9. Summary
ONCOZENE™ Microspheres are essentially equivalent to the predicate device Embozene Microspheres (K073417) but with a tighter controlled pH range (within the existing cleared specification). ONCOZENE™ Microspheres and the predicate device have indications for use, design, specifications, fundamental scientific technology, and packaging.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 4, 2013
CeloNova Biosciences, Inc. C/O Nicole C. Barber 18615 Tuscany Stone Suite 100 San Antonio, Texas 78258
Re: K130307
.
Trade/Device Name: ONCOZENE™ Microspheres Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: February 6, 2013 Received: February 7, 2013
Dear Ms. Barber:
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. Iisting 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.
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 803); good manufacturing practice requirements as set
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Page 2 - Nicole C. Barber
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Matthew G. Hillebrenner
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known) K130307
Device Name
Vascular Embolization Device
Indications for Use
ONCOZENE™ Microspheres are indicated for the embolization of hypervascular tumors and arteriovenous malformations.
Prescription Use_ × (Per 21 CFR 801. 109) AND/ OR
Over-The-Counter Use_
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Matthew GN Willebrenner
§ 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).