(192 days)
K#000137, K#010172
Not Found
No
The device description focuses on the physical material and its use in a milling process based on pre-supplied data, with no mention of AI or ML in the description, intended use, or performance studies.
No
The device is a material used to construct beam intensity modifiers for radiation therapy, not a therapeutic device itself. It shapes the radiation beam rather than directly treating a patient.
No
The device is a material used for constructing radiation therapy beam intensity modifiers, not for diagnosing medical conditions. It aids in the treatment process by shaping the radiation beam, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a "solid block of polyurethane and fillers," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The description clearly states that ParComPlast™ is a material used to construct beam intensity modifiers for radiation therapy treatment. It is a physical block that is milled and then used to shape a radiation beam.
- Lack of Biological Specimen Interaction: The device does not interact with or analyze any biological specimens from a patient. Its function is purely mechanical and related to shaping a radiation beam.
Therefore, based on the provided text, ParComPlast™ falls under the category of a medical device used in radiation therapy, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To shape the beam for a radiation therapy source.
Product codes
90 IXI
Device Description
ParComPlast™ is a solid block of polyurethane and fillers. It is intended to be used as material for construction of beam intensity modifiers for radiation therapy treatment. In use, a block of ParComPlast™ is placed into the holder of a milling machine such as described in our 510(k) K#883317, or, in similar machines produced by other manufacturers: a beam modifying filter is milled out using the x, y, z data supplied by either the planning computer or our contouring system. Once the filter is machined, it is mounted to the shadow tray plate using screws or double face tape and the plate is inserted into the holder on the accelerator for the patient's treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-Clinical Tests Performed for Determination of Substantial Equivalence: Product testing contained in this 510(k) submission demonstrated that ParComPlast™ can be used as compensator material on a similar level as aluminum (is used clinically). There is no difference in material behavior as materials used in the predicate devices.
Clinical Tests Performed: Not Applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K#000137, K#010172
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5710 Radiation therapy beam-shaping block.
(a)
Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.(b)
Classification. Class II.
0
DEC 2 7 2002
- EXHIBIT 1
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: (0 2 (497
Submitter's Identification: 1.
S&S Par Scientific 10625 Telge Road Houston, Texas 77095
Date Summary Prepared: June 14, 2002
Contact: Mr. Fred Sopenoff Manager, Radiology Division
2. Name of the Device:
ParComPlast™ Compensating Filter for Radiation Therapy
3. Predicate Device Information:
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- K#000137, Enhanced Compensating Filter, Computerized Medical Systems, Inc., St. Louis, MO
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- K#010172. Lead Blocks, Arplay Medical S.A., Cote D'or, France
4. Device Description:
ParComPlast™ is a solid block of polyurethane and fillers. It is intended to be used as material for construction of beam intensity modifiers for radiation therapy treatment. In use, a block of ParComPlast™ is placed into the holder of a milling machine such as described in our 510(k) K#883317, or, in similar machines produced by other manufacturers: a beam modifying filter is milled out using the x, y, z data supplied by either the planning computer or our contouring system. Once the filter is machined, it is mounted to the shadow tray plate using screws or double face tape and the plate is inserted into the holder on the accelerator for the patient's treatment.
5. Intended Use:
To shape the beam for a radiation therapy source.
1
6. Comparison to Predicate Devices:
-
- K#000137. Enhanced Compensating Filter, Computerized Medical Systems, Inc., St. Louis, MO, which is compensator milled directly from aluminum or brass block, and
-
- K#010172, Lead Blocks, Arplay Medical S.A., Cote D'or, France, which are lead blocks of varying sizes and heights to build compensator filters.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Product testing contained in this 510(k) submission demonstrated that ParComPlast™ can be used as compensator material on a similar level as aluminum (is used clinically). There is no difference in material behavior as materials used in the predicate devices.
8. Discussion of Clinical Tests Performed:
Not Applicable
ல் Conclusions:
The subject device, ParComPlast™ Compensating Filter for Radiation Therapy has the same intended use and similar characteristics as the predicate devices. Non-clinical testing supplied in our 510(k) submission demonstrates that there are no differences in their technological characteristics, thereby not raising any new questions of safety or effectiveness. Thus, ParComPlast™ is substantially equivalent to the predicate devices.
2
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 stylized eagle with three curved lines representing its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
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DEC 27. 2002
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850.
S & S Par Scientific % Ms. Susan D. Goldstein-Falk Official Correspondent MDI Consultants, Inc. 55 Northern Blvd., Suite 200 GREAT NECK NY 11021
Re: K021987 Trade/Device Name: ParComPlast™ Cornpensating Filter for Radiation Therapy Regulation Number: 21 CFR 892.5710 Regulation Name: Radiation therapy beam-shaping block Regulatory Class: II Product Code: 90 IXI Dated: October 8, 2002 Received: October 10, 2002
Dear Ms. Goldstein-Falk:
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 (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.
3
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,
Nancy C. Snogdin
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Exhibit B
Page 1 of 1
510(k) Number (if known): K021987
Device Name: ParComPlast™ Compensating Filter for Radiation Therapy Indications For Use:
To shape the beam from a radiation therapy source.
(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)
Hansil Huston
021987 510(k) Nu