(268 days)
No
The summary focuses on hardware integration and standard dosimetry protocols, with no mention of AI/ML.
Yes
The device is described as performing "Image guided stereotactic radiotherapy for the lesions, tumors & conditions anywhere in the body where radiation treatment is indicated for adults and Pediatric patients," which directly implies delivery of a therapy.
No.
Explanation: The device is described as a system for image-guided stereotactic radiotherapy, which is a treatment modality. While it performs quality assurance and beam data analysis, these functions are for ensuring the proper operation of the radiotherapy equipment, not for diagnosing patient conditions.
No
The device description explicitly mentions hardware components like an electromechanical arm, ion chamber, electrometer, water tank, and water reservoir, and discusses hardware verification and validation testing.
Based on the provided text, the SIDDHARTH-II device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use of SIDDHARTH-II is for image-guided stereotactic radiotherapy, which is a treatment method applied directly to the patient's body. The integrated Radiation Field Analyser (RFA) is used for machine quality assurance and beam data analysis, which are also related to the performance of the treatment device itself, not for testing samples taken from the body.
- Device Description: The description focuses on the components and functionalities related to delivering radiation therapy and performing quality control on the radiation beam. There is no mention of analyzing biological samples or performing tests on materials derived from the human body.
- Lack of IVD Characteristics: The text does not describe any features or processes typical of IVD devices, such as sample handling, reagent use, or analysis of biological markers.
The device is clearly intended for in vivo use (treatment of the patient) and quality control of the treatment equipment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
SIDDHARTH-II is intended to perform image guided stereotactic radiotherapy for the lessons, tumors & conditions anywhere in the body where radiation treatment is indicated for adults and Pediatric patients.
Integrated Radiation Field Analyser (RFA) of Siddharth-II is intended to collect beam data in water under the aspect of machine QA for the following purposes:
-
acceptance testing , periodic QA procedures, and/or commissioning of a radiation therapy system.
-
beam data analysis according to international therapy dosimetry protocols
-
acquisition, formatting and transfer of basic data to treatment planning systems
The indication for use of Immobilization & Patient Positioning devices (IMPACT) is to immobilize the patient during treatment by providing appropriate support and comfort which in turn leads to precise treatment delivery.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
SIDDHARTH-II, the subject device remains same as the most recently cleared predicate device SIDDHARTH-II (K210894). In addition, with the features and specifications of existing 510k cleared equipment, the Radiation Field analyzer (RFA) has been permanently integrated with gantry of Siddharth-II to perform beam data analysis as per international therapy dosimetry protocols.
The integrated RFA is retracted and accommodated within the gantry of the radiation therapy equipment after performing data dosimetry operations. This provides an integrated solution for validating the performance of a radiation therapy equipment using an RFA which is in-built with the radiation therapy equipment that is primarily employed for providing radiation treatments to patients.
The following functionalities can be achieved by using this RFA integrated with Siddharth-II.
- . Acceptance testing, Commissioning and Periodic Quality Assurance Measurements for radiation beams emitted by radiation therapy equipment SIDDHARTH-II
- . Beam data analysis according to international therapy dosimetry protocols
- . Collection of beam data for Treatment Planning System
The RFA setup consists of RFA electromechanical arm for 3-dimensional movement of radiation detector. Ion Chamber (Radiation Detector), Built-in Electrometer, RFA water tank and Water Reservoir. The design control procedures applied to the development of the SIDDHARTH-II and its modifications include requirements reviews, risk analysis, and verification and validation testing. The results of verification and validation activities demonstrate that the acceptance criteria have been met.
All other features and technological characteristics of the SIDDHARTH-II remains as cleared by K210894.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Image guided
Anatomical Site
anywhere in the body
Indicated Patient Age Range
adults and Pediatric patients.
Intended User / Care Setting
Hospital (Shielded bunker)
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)
Hardware and software verification and validation testing was conducted according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 quality Management System standard, ISO 14971 Risk Management Standard and the other FDA recognized consensus standards listed below. Test results showed conformance to applicable requirements specifications.
The non-clinical data support the safety of the device as compared to the predicate and the software verification and validation demonstrate that the subject device with additional RFA feature performs as intended. Panacea therefore considers the SIDDHARTH-II to be as safe and effective and to perform at least as well as the predicate devices. The imaging, radiation therapy capabilities of the subject device remain same with the existing 510k cleared device.
Software verification testing was conducted as required by FDA's Guidance for Industry and FDA Staff, "Guidance for the content of Premarket Submissions for Software contained in Medical Devices" as it concludes that the software of the subject device was considered as a "Major" level of concern and also it is in compliance with IEC 62304 Software Life cycle processes.
Electrical safety & electromagnetic (EMC) testing were conducted on the SIDDHARTH-II which verified complies with the IEC/ES 60601-1 standards for safety & IEC 60601-1-2 EMC standard.
Non-clinical performance testing for RFA feature of subject device was performed according to IEC 60731:2016 and to specific properties of Ion chamber (Radiation detector), Electrometer, and water phantom systems which included radiotherapy dose measurements i.e. with step by step measurements and also measurement accuracy with respect to radiation detector, positioning, reproducibility and mechanical alignment.
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.
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
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
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Panacea Medical Technologies Pvt Ltd. % Valli G. Plot No. 35, 4th Phase, Malur KIADB Industrial Area Malur, Kolar District 563130 INDIA
Re: K222762
Trade/Device Name: SIDDHARTH-II; IMPACT Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: May 4, 2023 Received: May 9, 2023
Dear Valli G .:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
June 8, 2023
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
| Lora D. | Digitally signed by Lora |
|---|---|
| Weidner -S | D. Weidner -S |
| Date: 2023.06.08 16:14:57 | |
| -04'00' |
Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222762
Device Name
SIDDHARTH-II and IMPACT
Indications for Use (Describe)
SIDDHARTH-II is intended to perform image guided stereotactic radiotherapy for the lessons, tumors & conditions anywhere in the body where radiation treatment is indicated for adults and Pediatric patients.
Integrated Radiation Field Analyser (RFA) of Siddharth-II is intended to collect beam data in water under the aspect of machine QA for the following purposes:
-
acceptance testing , periodic QA procedures, and/or commissioning of a radiation therapy system.
-
beam data analysis according to international therapy dosimetry protocols
-
acquisition, formatting and transfer of basic data to treatment planning systems
The indication for use of Immobilization & Patient Positioning devices (IMPACT) is to immobilize the patient during treatment by providing appropriate support and comfort which in turn leads to precise treatment delivery.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
| I. | Submitter's Information | |
|---|---|---|
| Company Name: | Panacea Medical Technologies Pvt Ltd | |
| Company Address: | Plot No.35, 4th Phase, Malur KIADB Industrial Area, | |
| Malur-563130, Kolar District, INDIA | ||
| Contact Name: | Ms. Valli | |
| Contact Number : | +91 9343779160 | |
| Date prepared: | 10-Sep-22 | |
| III. | Device Information | |
| Name of the Device: | SIDDHARTH-II;IMPACT | |
| Proprietary Name: | Panacea Medical technologies Pvt. Ltd | |
| Common Name: | Linear accelerator for radiation therapy system | |
| Classification Name: | Medical charged-particle radiation therapy system | |
| Regulatory Class: | Class II | |
| Product Code: | IYE |
IV. Predicate Device
| Panacea Device: SIDDHARTH-II | |
|---|---|
| Legally Marketed Proposed | Primary Predicate Device |
| Predicate Device Name | SIDDHARTH-II;IMPACT |
| Trade/Proprietary Name | Panacea Medical Technologies Pvt. Ltd |
| 510(k) Number | K210894 |
| Date Cleared | 28-Sep-21 |
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| Device Classification: | Class II |
|---|---|
| Product Code: | IYE |
| Panacea Device: | SIDDHARTH-II | |
|---|---|---|
| Legally Marketed reference Device | Reference device | |
| Name | Dose View 3D | |
| Trade/Proprietary Name | Standard Imaging | |
| 510(k) Number | K103193 | |
| Date Cleared | 27-Dec-2010 | |
| Device Classification: | Class II | |
| Product Code: | IYE |
v. Device Description
SIDDHARTH-II
SIDDHARTH-II, the subject device remains same as the most recently cleared predicate device SIDDHARTH-II (K210894). In addition, with the features and specifications of existing 510k cleared equipment, the Radiation Field analyzer (RFA) has been permanently integrated with gantry of Siddharth-II to perform beam data analysis as per international therapy dosimetry protocols.
The integrated RFA is retracted and accommodated within the gantry of the radiation therapy equipment after performing data dosimetry operations. This provides an integrated solution for validating the performance of a radiation therapy equipment using an RFA which is in-built with
5
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the radiation therapy equipment that is primarily employed for providing radiation treatments to patients.
The following functionalities can be achieved by using this RFA integrated with Siddharth-II.
- . Acceptance testing, Commissioning and Periodic Quality Assurance Measurements for radiation beams emitted by radiation therapy equipment SIDDHARTH-II
- . Beam data analysis according to international therapy dosimetry protocols
- . Collection of beam data for Treatment Planning System
The RFA setup consists of RFA electromechanical arm for 3-dimensional movement of radiation detector. Ion Chamber (Radiation Detector), Built-in Electrometer, RFA water tank and Water Reservoir. The design control procedures applied to the development of the SIDDHARTH-II and its modifications include requirements reviews, risk analysis, and verification and validation testing. The results of verification and validation activities demonstrate that the acceptance criteria have been met.
All other features and technological characteristics of the SIDDHARTH-II remains as cleared by K210894.
Comparison of Technological Characteristics with the predicate Device
Compared with the predicate device SIDDHARTH-II (K210894), the basic operation and technological characteristics are the same. Operational differences are described in the Instructions for use of SIDDHARTH-II.
Significant differences between the modified device to the existing 510k cleared device appears below.
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| SPECIFICATION | CLEARED DEVICE
(SIDDHARTH-II_K210894) | MODIFIED DEVICE
(SIDDHARTH-II) |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | SIDDHARTH-II is intended to
perform image guided
stereotactic radiotherapy for the
lesions, tumors & conditions
anywhere in the body where
radiation treatment is indicated
for adults and Pediatric patients. | Unchanged |
| Indication for use | SIDDHARTH-II is intended to
perform image guided
stereotactic radiotherapy for the
lesions, tumors & conditions
anywhere in the body where
radiation treatment is indicated
for adults and Pediatric patients. | SIDDHARTH-II is intended to
perform image guided stereotactic
radiotherapy for the lesions, tumors
& conditions anywhere in the bodyindicated for adults and Pediatric
patients. |
| | The indication for use of
Immobilization & Patient
Positioning devices (IMPACT)
is to immobilize the patient
during treatment by providing
appropriate support and comfort
which in turn leads to precise
treatment delivery. | Integrated Radiation Field Analyzer
(RFA) of Siddharth-II is intended to
collect beam data in water under the
aspect of machine QA for the
following purposes:
-
acceptance testing, periodic QA
procedures, and/or commissioning
of a radiation therapy system. -
beam data analysis according to
international therapy dosimetry |
| SPECIFICATION | CLEARED DEVICE
(SIDDHARTH-II_K210894) | MODIFIED DEVICE
(SIDDHARTH-II) |
| | | protocols -
acquisition, formatting and transfer
of basic data to treatment planning
systems |
| | | The indication for use of
Immobilization & Patient
Positioning devices (IMPACT) is to
immobilize the patient during
treatment by providing appropriate
support and comfort which in turn
leads to precise treatment delivery. |
| User Interface Device | Control Console PC | Unchanged |
| Use Environment | Hospital (Shielded bunker) | Unchanged |
| Target to Axis Distance
(TAD) (in cm) | 100 | Unchanged |
| Gantry range of Rotation
(°) | ±185 | Unchanged |
| Beam Stopping Devices | Yes | Unchanged |
| Type of Gantry | Ring | Unchanged |
| Beam Energy | 6 MV | Unchanged |
| SPECIFICATION | CLEARED DEVICE
(SIDDHARTH-II_K210894) | MODIFIED DEVICE
(SIDDHARTH-II) |
| Patient Support System | • Lateral
• Longitudinal
• Vertical
• Theta
• Pitch
• Roll | Unchanged |
| Treatment Modality | • IGRT With Kv Imaging
• 3D CRT Treatment
• IMRT Treatment
• VMAT Treatment
• SBRT Treatment | Unchanged |
| In-built Automated QA
Tool - Radiation Field
Analyzer (RFA) | No | Yes |
| RFA arm Motions
(To perform 3-
dimensional radiation
dose measurements) | No | • Offset Motion (X)
• Linear Motion (Y)
• Vertical Motion (Z) |
| Software | SIDDHARTH-II provides an
intuitive and simplified
workflow for the user to enter,
plan, edit and execute patient
treatment swiftly through
treatment module. | In addition with treatment module,
RFA Dosimetry Module has been
integrated in SIDDHARTH-II
Software to control RFA motions &
to perform RFA QA Applications |
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Indications for Use
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SIDDHARTH-II is intended to perform image guided stereotactic radiotherapy for the lesions, tumors & conditions anywhere in the body where radiation treatment is indicated for adults and Pediatric patients.
Integrated Radiation Field Analyzer (RFA) of Siddharth-II is intended to collect beam data in water under the aspect of machine QA for the following purposes:
- acceptance testing, periodic OA procedures, and/or commissioning of a radiation therapy system.
- beam data analysis according to international therapy dosimetry protocols
- acquisition, formatting, and transfer of basic data to treatment planning systems
The indication for use of Immobilization & Patient Positioning devices (IMPACT) is to immobilize the patient during treatment by providing appropriate support and comfort which in turn leads to precise treatment delivery.
VI. Substantial equivalence summarv
Panacea claims the modified device in this 510k submission to be substantially equivalent to the predicate devices previously cleared by the FDA in the 510(k) specified above.
Panacea claims this equivalence because the proposed devices have equivalent designs, intended uses, target population, patient positioning and used materials. The integration and performance of the new Radiation Field Analyzer for QA purposes was supported by the reference device. Although small technological differences exist, these products have similar product characteristics for use in radiotherapy and further detailed information is included in Substantial Equivalence Discussion of this submission.
Performance Data VII.
Hardware and software verification and validation testing was conducted according to the FDA Quality System Regulation (21 CFR $820), ISO 13485 quality Management System standard, ISO 14971 Risk Management Standard and the other FDA recognized consensus standards listed below. Test results showed conformance to applicable requirements specifications.
10
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The non-clinical data support the safety of the device as compared to the predicate and the software verification and validation demonstrate that the subject device with additional RFA feature performs as intended. Panacea therefore considers the SIDDHARTH-II to be as safe and effective and to perform at least as well as the predicate devices. The imaging, radiation therapy capabilities of the subject device remain same with the existing 510k cleared device.
Software verification testing was conducted as required by FDA's Guidance for Industry and FDA Staff, "Guidance for the content of Premarket Submissions for Software contained in Medical Devices" as it concludes that the software of the subject device was considered as a "Major" level of concern and also it is in compliance with IEC 62304 Software Life cycle processes.
Electrical safety & electromagnetic (EMC) testing were conducted on the SIDDHARTH-II which verified complies with the IEC/ES 60601-1 standards for safety & IEC 60601-1-2 EMC standard.
Non-clinical performance testing for RFA feature of subject device was performed according to IEC 60731:2016 and to specific properties of Ion chamber (Radiation detector), Electrometer, and water phantom systems which included radiotherapy dose measurements i.e. with step by step measurements and also measurement accuracy with respect to radiation detector, positioning, reproducibility and mechanical alignment.
Standards Conformance
SIDDHARTH-II conforms with the FDA recognized standards and other international standards listed below.
ANSI/AAMI ES60601-1, IEC 60601-1-3, IEC 60601-2-1, IEC 60601-2-68, IEC 60601-1-6, IEC 60601-1-2, IEC 62274, IEC 61217, IEC 62304, ISO 10993-1, ISO 10993-5, ISO 10993-10, IEC 60825-1, IEC 60976, IEC 60731, ISO 15223-1, and ISO 14971
VIII. Clinical Testing
Similar devices have been on the market for many years with proven safety and efficacy for the use of the device. Based on this history and the use of the device, clinical testing was not
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necessary to support substantial equivalence data. The non-clinical testing performed supports safety and efficacy of the devices in comparison to the predicate and provides data to show substantial equivalence to the predicated device.
IX. Conclusion
The results of verification, validation & safety standards testing demonstrates that the modified SIDDHARTH-II complies to the specified safety & performance criteria & it is substantially equivalent to the predicate device which do not raise any new issues on safety & effectiveness.