(203 days)
No
The description focuses on deterministic calculations based on updated models and data, with no mention of AI/ML terms or methodologies.
No
The device is used to estimate absorbed radiation dose, not to provide therapy.
No
The device estimates absorbed radiation dose and effective whole-body dose, which are calculations based on administered radionuclides and biodistribution data, rather than directly diagnosing a medical condition or disease.
Yes
The device description explicitly states it is a modification of a previous version (K033960) and focuses on updated models, nuclides, decay data, and phantoms. There is no mention of any associated hardware component being part of the device itself. The performance studies focus on software verification and validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to calculate absorbed radiation dose and effective whole-body dose based on supplied biodistribution data. This is a calculation and modeling tool related to radiation dosimetry, not a test performed on biological samples in vitro (outside the living body).
- Device Description: The description focuses on software modifications, new human models, nuclides, decay data, and anthropomorphic phantoms. These are all components of a computational tool for dose estimation, not an IVD device which would typically involve reagents, instruments for analyzing biological samples, etc.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
The device's function is to process input data (biodistribution) to provide estimates of radiation dose within the body, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The intended use of OLINDA/EXM is to provide estimates (deterministic) of absorbed radiation dose at the whole organ level as a result of administering any radionuclide and to calculate effective whole-body dose. This is dependent on input data regarding bio distribution being supplied to the application.
Product codes
IYX
Device Description
The OLINDA/EXM® v2.0 is a modification of OLINDA/EXM® v1.1 (K033960) and includes new human models and nuclides. OLINDA/EXM® 2.0 employs a new set of decay data recommended by the International Commission on Radiological Protection (ICRP). OLINDA/EXM® 2.0 introduces a new series of anthropomorphic human body models (phantoms), so new values of Specific Absorbed Fractions (SAF), di (T←S) were generated. These phantoms were based on updated values of the mass of the target region (mr) recommended by the ICRP. The base product design of OLINDA/EXM® V2.0 is the same as for the OLINDA/EXM® V1.1 (K033960).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
whole organ level, whole-body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
The tests for verification and validation followed Hermes Medical Solutions AB design controlled procedures. The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria. Comparisons were made between OLINDA/EXM® v2.0 and OLINDA/EXM® v1.1 (K033960). The results showed a good compliance.
Key Metrics
Not Found
Predicate Device(s)
OLINDA/EXM® v1.1 (K033960)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1100 Scintillation (gamma) camera.
(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class I (general controls).
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 19, 2017
Hermes Medical Solutions AB % Joakim Arwidson Quality Manager Skeppsbron 44 11130 Stockholm SWEDEN
Re: K163687
Trade/Device Name: OLINDA/EXM v2.0 Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (Gamma) Camera Regulatory Class: Class I Product Code: IYX Dated: July 5, 2017 Received: July 7, 2017
Dear Joakim Arwidson:
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. 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 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163687
Device Name OLINDA/EXM v2.0
Indications for Use (Describe)
The intended use of OLINDA/EXM is to provide estimates (deterministic) of absorbed radiation dose at the whole organ level as a result of administering any radionuclide and to calculate effective whole-body dose. This is dependent on input data regarding bio distribution being supplied to the application.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510 (k) SUMMARY
A. Submitted by:
- Submitters name and address: Hermes Medical Solutions AB Skeppsbron 44 111 30 Stockholm Sweden
. Submitters telephone number
| Phone: | +46 8 19 03 25 |
|---|---|
| Cell: | +46 708 19 03 08 |
| Fax: | +46 8 18 43 54 |
| E-mail: | joakim.arwidson@hermesmedical.com |
● Contact person
Joakim Arwidson Quality Manager Hermes Medical Solutions AB Skeppsbron 44 111 30 Stockholm Sweden
- . Reqistration number 9710645
B. Preparation date:
2016-11-23
C. Proprietary/Trade name, Common name, Classification name:
- Proprietary/Trade name . OLINDA/EXM® v2.0
- . Common name Scintillation (gamma) camera.
- . Classification name Scintillation (gamma) camera, Class I, 21CFR892.1100.
D. Legally marketed device (predicate device):
Following legally marketed device has been used for comparison.
- OLINDA/EXM® v1.1 (K033960) ●
E. Description of the device that is subject of this premarket notification:
The OLINDA/EXM® v2.0 is a modification of OLINDA/EXM® v1.1 (K033960) and includes new human models and nuclides. OLINDA/EXM® 2.0 employs a new set of decay data recommended by the International Commission on Radiological Protection (ICRP). OLINDA/EXM® 2.0 introduces a new series of anthropomorphic human body models (phantoms), so new values of Specific Absorbed Fractions (SAF), di (T←S) were generated. These phantoms were based on updated values of the mass of the target region (mr) recommended by the ICRP.
4
The base product design of OLINDA/EXM® V2.0 is the same as for the OLINDA/EXM® V1.1 (K033960).
F. Intended use:
The intended use of OLINDA/EXM is to provide estimates (deterministic) of absorbed radiation dose at the whole organ level as a result of administering any radionuclide and to calculate effective whole-body dose. This is dependent on input data regarding bio distribution being supplied to the application.
G. Technological characteristics:
The proposed device OLINDA/EXM® v2.0 has the same technological characteristics as the original device OLINDA EXM® v1.1 and the same indication for use.
H. Testing:
The tests for verification and validation followed Hermes Medical Solutions AB design controlled procedures. The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria.
I. Substantially Equivalent/Conclusions:
The proposed device OLINDA/EXM® v2.0 and the predicate devices OLINDA/EXM® v1.1 (K033960) have the same indication for use.
The proposed device will use similar technology and fundamental concepts and operation are also the same, as described in the 510(k) submission.
Comparisons were made between OLINDA/EXM® v2.0 and OLINDA/EXM® v1.1 (K033960). The results showed a good compliance.
In summary, the OLINDA/EXM® v2.0 described in this submission is in our opinion substantially equivalent to the predicate device.