(245 days)
No
The document does not mention AI, ML, or related terms, nor does it describe any characteristics typically associated with AI/ML-powered devices (e.g., training/test sets, performance metrics like AUC).
No
This device is described as treatment planning software, an accessory to linear accelerators used for radiation therapy, indicated for use in the planning of 3D radiation therapy, not for delivering the therapy itself.
No
The device is described as a "radiosurgery treatment planning software module" and is "indicated for use in the planning of 3 dimensional radiation therapy." Planning therapy is not the same as diagnosing a condition.
Yes
The device is described as a "software module" for an existing radiotherapy treatment planning system and is an "accessory to linear accelerators." The description focuses solely on the software's function in planning radiation therapy and does not mention any associated hardware components being part of this specific submission.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "planning of 3 dimensional radiation therapy." This is a therapeutic planning function, not a diagnostic test performed on samples taken from the human body.
- Device Description: It's described as a "stereotactic radiosurgery treatment planning software module." This reinforces its role in planning treatment, not performing in vitro diagnostics.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances or markers, or providing diagnostic information about a patient's health status.
IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is clearly related to planning radiation therapy, which is a treatment modality.
N/A
Intended Use / Indications for Use
It is intended for use in the planning of 3 dimensional radiation therapy.
ERGO SRS is stcreotactic radiosurgery module for DMLCIV-ERGO (K001163). It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning of 3 dimensional radiation therapy.
Product codes (comma separated list FDA assigned to the subject device)
90 MUJ
Device Description
ERGO SRS is a stereotactic radiosurgery treatment planning software module for 3D Line USA's ERGO radiotherapy treatment planning system (K001163).
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)
Not Found
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.
PLATO SRS V2, K010784
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
APPENDIX 6: 510 (K) SUMMARY
K03/281
510(k) Summary As required by 807.92 For ERGO SRS Prepared on January 17, 2003
Submitted by: 3D Line USA, Inc. 11419 Cronridge Dr. Suite 15 Owings Mills, MD 21117
Tel. 410-581-6701
Fax: 410-581-9007
Contact Person: Nader Salehi Vice President
Device Trade Name: ERGO SRS
Common Name: Stereotactic radiosurgery treatment planning module
Classification: Medical charged-particle radiation therapy system, Class II Sec. 21 CFR 892.5050
Predicate Device: PLATO SRS V2, K010784
Manufactured by: Nucletron Corporation, 7080 Columbia Gateway Drive, Columbia, MD 21046-2133
Description of the Device: ERGO SRS is a stereotactic radiosurgery treatment planning software module for 3D Line USA's ERGO radiotherapy treatment planning system (K001163).
Intended Use for the Device: It is intended for use in the planning of 3 dimensional radiation therapy.
Substantial Equivalence to Predicate Device: ERGO SRS is identical to PLATO SRS V2. It is the same software integrated with 3D Line USA's ERGO system rather than Nucletron's PLATO system.
1
Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 2003
Mr. Nader Salehi Vice President 3D Line USA, Inc. Reston Executive Center 12100 Sunset Hills Road, Suite 150 RESTON VA 20190
Re: K031281 Trade/Device Name: ERGO SRS Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charge-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: December 4, 2003 Received: December 8, 2003
Dear Mr. Salehi:
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 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.
2
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 one of the following numbers, based on the regulation number at the top of the 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" (21CFR Part 807.97) you may obtain. 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. Brygdon
Nancy C. B rogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
3
Image /page/3/Picture/0 description: The image shows a logo with the text "3D LINE USA". The "3D" is stacked on top of "LINE", and "USA" is below "LINE". The "3D" is large and bold, and the "LINE" and "USA" are smaller. The logo is black and white.
Applicant: 3D Line USA, Inc._
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: __ ERGO SRS______________________________________________________________________________________________________________________________________________________
Indications For Use:
ERGO SRS is stcreotactic radiosurgery module for DMLCIV-ERGO (K001163). It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning of 3 dimensional radiation therapy.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Daniel R. Ingram
(Division Sign-Off)
Division of Reproductive, Abdor and Padiological Devices 510(k) Number _
Prescription Use
3D Line USA, Inc. 11419 Cronridge Drive / Suite 15 / Owings Mills, Maryland 21117 / Office: 410-581-6701 / Fax: 410-581-9007