(200 days)
K#041125, K#061941
Not Found
No
The summary does not mention AI, ML, or related terms, and the description focuses on the mechanical and electrical components and standard performance testing.
Yes
The device is a teletherapy device indicated for stereotactic irradiation, which is a treatment for medical conditions, thus making it a therapeutic device.
No.
Explanation: The device is a teletherapy device used for stereotactic irradiation, which is a treatment modality, not a diagnostic one.
No
The device description explicitly lists hardware components such as "60Co Radiation sources", "Main unit (including mechanical system and electric system)", and "Stereotactic system", indicating it is a physical device with software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "stereotactic irradiation of intracranial structures." This describes a therapeutic procedure using radiation to treat structures within the head.
- Device Description: The description details a "teletherapy device" composed of radiation sources, mechanical and electrical systems, a stereotactic system, and a treatment planning system. These are components of a radiation therapy system, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to be used in vitro (outside the living body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Rotating Gamma System Infini™ is a therapeutic device used in vivo (within the living body) to deliver radiation treatment.
N/A
Intended Use / Indications for Use
The Rotating Gamma System Infini™ is a teletherapy device indicated for use in stereotactic irradiation of intracranial structures.
Product codes (comma separated list FDA assigned to the subject device)
90IWB, IWB, MUJ
Device Description
The Rotating Gamma System Infini™ is a teletherapy device indicated for use in stereotactic irradiation of intracranial structures. The system is composed of four parts:
- 60Co Radiation sources
- Main unit (including mechanical system and electric system)
- Stereotactic system
- Treatment planning system
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial structures
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 testing was conducted to validate and verify that the Rotating Gamma System Infini" met all design specifications and is substantially equivalent to the predicate device.
Rotating Gamma System Infinit has also been tested to assure compliance to the requirements of various published standards, including IEC60601-1, IEC60601-2, ISO14971 and ISO 2919. Performance testing, including software validation testing to a major level of software concern for the Rotating Gamma System Infini " device, was conducted to verify that the operation of the entire Infini™ system along with its electrical control system has not been adversely affected by the device modifications.
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.
K#041125, K#061941
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
§ 892.5750 Radionuclide radiation therapy system.
(a)
Identification. A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.(b)
Classification. Class II.
0
MASEP
This summary of Special 510(k) safety and Effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and 21 CFR807.92.
| The assigned 510(k) number is: | K102533 |
|---|---|
| Submitter's Identification: | MASEP Medical Science & Technology Development (Shenzhen) Co., Ltd. |
| Submitter's Addresses: | 601, 14th Building, Software Yard, Tech Mid Road 2nd, High-Tech Zone, |
| 518057 Shenzhen, P.R. China | |
| Date Summary Prepared: | January 11, 2011 |
| Contact Person: | Mr. Danny Qiu |
| CEO | |
| Masep Infini Medical Science Technology Development Co. LTD. | |
| 17870 Castleton Street, Suite 395, City of Industry, CA 91748 USA | |
| Tel: (626) 965-3200 Fax: (626) 965-3222 | |
| Http://www.masepinfini.com | |
| Name of Device: | Rotating Gamma System Infini™ |
| Classification: Radionuclide Radiation Therapy System | |
| The Radiology Panel of DRAED has classified this radiology therapeutic | |
| device as Class II, Performance Standards, 21 CFR Part 892.5760, | |
| Radionuclide Radiation Therapy System, Product Code 90IWB. | |
| Predicate Device Information: | The Rotating Gamma System Infini™ is substantially equivalent to the |
| Gamma Therapy System (K#041125), manufactured and marketed by | |
| MASEP Medical Science & Technology Development (Shenzhen) Co., | |
| Ltd. and the Leksell Gamma Knife ® Perfexion™ (K#061941), | |
| manufactured and marketed by Elekta Instruments AB for treating |
intracranial disease. The equivalence is based on the intended use, performance specifications, materials and technology characteristics.
..
" …
. IM
1
MASEP
MASEP Medical Science & Technology Development (Shenzhen) Co., Ltd.
510(k) Documents
| Exhibit #1 | 510(k) Summary | ||
|---|---|---|---|
| Page: 2 of 3 |
| Device Description: | The Rotating Gamma System Infini™ is a teletherapy device indicated for use in stereotactic irradiation of intracranial structures. The system is composed of four parts: |
|---|---|
| 60Co Radiation sourcesMain unit (including mechanical system and electric system)Stereotactic systemTreatment planning system |
| Intended Use: | The Rotating Gamma System Infini™ is a teletherapy device indicated for |
|---|---|
| ---------------------- | ------------------------------------------------------------------------- |
Technical Characteristics Comparison with MASEP Predicate Device:
The Rotating Gamma System Infini TM is an improvement of the MASEP Gamma Therapy System for which MASEP was cleared under K041125. All safety and effectiveness testing (including risk analysis and performance testing) were conducted and completed with passing results.
use in stereotactic irradiation of intracranial structures
Infini TM has the following modifications:
- · Change in treatment bed movement. · · · · · · · · · · · · · · · · · · · · · · ·
MASEP Gamma Therapy System: Bed only moves in Z axis;
InfiniTM: Bed moves in 3 dimensions (X, Y and Z axis).
- · Change in collimator diameter sizes
MASEP Gamma Therapy System: Φ4 mm, Φ1 mm, Φ18 mm, Φ22 mm, total of 5 sizes
Infini™: Φ4 mm, Φ8 mm, Φ18 mm, Φ18 mm, total of 4 sizes eliminating Φ22 mm collimator.
- · Change in number of Co radioactive sources and total initial loading activity
MASEP Gamma Therapy System: number of 00 radioactive sources = 25, total initial loading ≥ 6500 Ci.
Infini "M: number of 00 radioactive sources = 30, total initial loading ≥ 7800 Ci.
- Change in radioactive source switching design �
MASEP Gamma Therapy System: Through rotation of the switching body, collimator passage is opened thus permitting passage of radiation. Likewise through reverse rotation of switching body, collimator passage is blocked thus closing radiation passage.
Infini ™: Through rotation of the 6 switching valves, collimator passage is opened thus permitting passage of radiation. Likewise through reverse rotation of 6 switching valves, collimator passage is blocked thus closing radiation passage.
For all design changes, a risk analysis and safety and effectiveness testing were performed. All testing that was conducted showed passing results.
2
MASEP Medical Science & Technology Development (Shenzhen) Co., Ltd. 510(k) Documents Exhibit #1
Comparison to Predicate Device:
Both the Infinit™ and the Gamma Therapy System devices (K041125) are intended for stereotactic irradiation of intra-cranial structures. Infini™ can perform the same function as realized by the Gamma Therapy System (K041125).
The performance of the subject Rotating Gamma System Infini™ is similar in both geometric accuracy and dosimetric characteristics to the predicate device, with other similar technological characteristics,
Equivalencies include: same principle, intended use, energy used or transmitted, materials, similar design and operations. Similarities are reflected in safety, effectiveness, labeling, compatibility, standards, and application characteristics.
Discussion of Non-Clinical Testing Performed for Determination of Substantial Equivalence:
Non-clinical testing was conducted to validate and verify that the Rotating Gamma System Infini" met all design specifications and is substantially equivalent to the predicate device.
Rotating Gamma System Infinit has also been tested to assure compliance to the requirements of various published standards, including IEC60601-1, IEC60601-2, ISO14971 and ISO 2919. Performance testing, including software validation testing to a major level of software concern for the Rotating Gamma System Infini " device, was conducted to verify that the operation of the entire Infini™ system along with its electrical control system has not been adversely affected by the device modifications.
Conclusion:
The Rotating Gamma System Infini™ has the same intended use and similar characteristics as the predicate devices. Testing demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. The Rotating Gamma System Infini™ is substantially equivalent to the predicate devices.
inLini
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
MASEP Medical Science & Technology Development (Shenzhen) Co., Ltd. % Ms. Susan D. Goldstein-Falk Official Correspondent mdi Consultants, Inc. 55 Northern Boulevard, Suite 200 MAR 2 2 25jj GREAT NECK NY 11021
Re: K102533
Trade/Device Name: Rotating Gamma System Infini™ (Infini™) Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: IWB. MUJ Dated: March 14, 2011 Received: March 16, 2011
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of
4
Page 2
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
of 1
SEP Medical Science & Technology Development (Shenzhen) Co., Ltd. 0(k) Documents
Exhibit B Page: 1
Rotating Gamma System Infini™
Indications for Use Statement
510(k) Number (if known): צום 25333
Device Name: Rotating Gamma System Infini™ (Infini™)
Indications for Use:
The Rotating Gamma System Infini™ (Infini™) is a teletherapy device indicated for use in stereotactic irradiation of intracranial structures.
Prescription Use _ X_ AND/OR (Part 21 CFR 801 Subpart D)
810x
Over-The Counter Use
(21 CFT 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S. Patel
(Division Sign Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
infilini™