(221 days)
Vista Scientific Barium Sulfate™ is intended for use as an additive to Codman Cranioplastic™ (Type 1-Slow set) to provide radiopacity for imaging purposes.
Vista Scientific Barium Sulfate is a dry powder supplied sterile and non-pyrogenic for use as a radiopacifying additive to Codman Cranioplastic™ (Type 1-Slow set) bone cement. The Barium Sulfate is supplied in a quantity of 6 grams, packaged in a closed 120 mL polymer container, and sealed within a double sterile peel pouch package configuration.
The provided document (K024359 for Vista Scientific Barium Sulfate) is a 510(k) summary and FDA clearance letter, which describes the device and its intended use, and states that it is substantially equivalent to a predicate device. This type of document typically does not contain the detailed performance study results you are asking for (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).
The purpose of a 510(k) submission for a device like this (an additive to a bone cement to provide radiopacity) is to demonstrate substantial equivalence to a legally marketed predicate device, primarily through performance, biocompatibility, and microbiological testing. It focuses on showing the new device performs as designed and is suitable for its intended use, similar to its predicate.
Therefore, many of the specific details you requested are not available within the provided text.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria nor detailed quantitative performance metrics for the device itself (e.g., specific radiopacity values or thresholds). It broadly states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performs as designed and is suitable for intended use | "Performance, biocompatibility and microbiological testing have been conducted, and the results of the testing verify that the Vista Scientific Barium Sulfate performs as designed and is suitable for its intended use." (Section: Testing in Support of Substantial Equivalence) |
| Substantial equivalence to predicate device | "Vista Scientific Barium Sulfate is substantially equivalent to the predicate device with regards to device design, intended use, patient population and anatomical site. Any differences in technological characteristics between the Vista Scientific Barium Sulfate and the predicate device do not raise any new issues of safety or effectiveness." (Section: Substantial Equivalence) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document mentions "Performance, biocompatibility and microbiological testing," but does not detail the sample sizes, study design (retrospective/prospective), or data provenance for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. Given the nature of a radiopacifying additive, "ground truth" would likely relate to objective measurements of radiopacity rather than expert interpretation of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
An MRMC study is not applicable and was not done for this device. This device is an additive to bone cement, not an AI or imaging diagnostic tool. The concept of "human readers improve with AI" does not apply here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone algorithm performance study is not applicable and was not done for this device. This device is an additive to bone cement, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for a radiopacifying agent would likely be objective physical or chemical measurements of its ability to absorb X-rays and provide contrast, compared to a standard. The document does not explicitly state the specific type of ground truth, but it would not be expert consensus, pathology, or outcomes data in the traditional sense for an imaging diagnosis. The evaluation would focus on the material properties.
8. The sample size for the training set
This information is not applicable and not provided. As this is not an AI/machine learning device, there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable and not provided. As this is not an AI/machine learning device, there is no "training set."
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AUG - 8 2003
5 510(k) Summary
This summary of the 510(k) premarket notification for the Vista Scientific Barium Sulfate is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Manufacturer
Vista Scientific, LLC 7960 Niwot Road, Unit B-7 Niwot, CO 80503 Telephone: (303) 652-1501 Registration #: FDA forms 2891 and 2892 submitted. FDA letter acknowledging receipt of forms received 6 May 2003.
Contact Person
Jonathan Modine General Manager
Date Prepared
August 1, 2003
Device Classification Name
Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty, Product Code MYU (Class II)
Trade Name
Vista Scientific AxioView Barium Sulfate
Generic/Common Name
Barium Sulfate USP
Predicate Device
Biotrace® Bone Cement Radio-Opacifier (Bryan Corporation) (K002063)
Action taken to comply with Section 514 of the Act
No applicable mandatory performance standards or special controls exist for this device.
Intended Use
Vista Scientific Barium Sulfate" is intended for use as an additive to Codman Cranioplastic™ (Type 1-Slow set) to provide radiopacity for imaging purposes.
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Product Description
Vista Scientific Barium Sulfate is a dry powder supplied sterile and non-pyrogenic for use as a radiopacifying additive to Codman Cranioplastic™ (Type 1-Slow set) bone cement. The Barium Sulfate is supplied in a quantity of 6 grams, packaged in a closed 120 mL polymer container, and sealed within a double sterile peel pouch package configuration.
Substantial Equivalence
Vista Scientific Barium Sulfate is intended for use as an additive to Codman Cranioplastic™ (Type 1-Slow set) to provide radiopacity for imaging purposes.
It is substantially equivalent to other devices currently on the market for use as a radiopacifying additive for imaging purposes when used as an additive to Codman Cranioplastic™ (Type 1-Slow set).
Vista Scientific Barium Sulfate is equivalent to Biotrace® Bone Cement Radio-Opacifier (Bryan Corporation, K002063). Vista Scientific Barium Sulfate is substantially equivalent to the predicate device with regards to device design, intended use, patient population and anatomical site. Any differences in technological characteristics between the Vista Scientific Barium Sulfate and the predicate device do not raise any new issues of safety or effectiveness.
Testing in Support of Substantial Equivalence
Performance, biocompatibility and microbiological testing have been conducted, and the results of the testing verify that the Vista Scientific Barium Sulfate performs as designed and is suitable for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 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 SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 2003
Mr. Jonathan Modine General Manager Vista Scientific, LLC 7960 Niwot Road Unit B-7 Niwot, CO 80503
Re: K024359
Trade Name: Vista Scientific Barium Sulfate TM Regulation Number: 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: Class II Product Code: MYU Dated: June 3, 2003 Received: June 25, 2003
Dear Mr. Modine:
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
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Page 2 – Mr. Jonathan Modine
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
fal 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
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Statement of Indications for Use 4
INDICATIONS FOR USE
510(k) Number (if known):
Ko24359
Device Name: Vista Scientific Barium Sulfate™
Indications for Use:
Vista Scientific Barium Sulfate™ is intended for use as an additive to Codman Cranioplastic™ (Type 1-Slow set) to provide radiopacity for imaging purposes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 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 K624359
§ 882.5300 Methyl methacrylate for cranioplasty.
(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).