(52 days)
No
The description focuses on a mechanical spatial reference system for patient positioning, with no mention of AI/ML, image processing, or performance metrics typically associated with AI/ML devices.
No.
The device is a localization system and accessory to linear accelerators used for radiation therapy, indicated for patient positioning and planning of 3D radiation therapy, but it does not directly treat or prevent disease itself.
No
This device is a patient localization system used for positioning patients during radiation therapy, not for diagnosing medical conditions. It aids in accurate treatment delivery based on pre-existing diagnostic images and treatment plans.
No
The device description explicitly states it is a "spatial reference system external to the body of a patient," which describes a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "patient localization system for use in stereotactic radiosurgery" and an "accessory to linear accelerators used for radiation therapy." This describes a device used on the patient for treatment planning and delivery, not a device used to examine specimens in vitro (outside the body).
- Device Description: The description reinforces this by stating it's a "spatial reference system external to the body of a patient undergoing radiotherapy treatment."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on patient positioning and spatial referencing for radiation therapy.
N/A
Intended Use / Indications for Use
It is intended for use in the planning and conduct of 3 dimensional radiation therapy with a linear accelerator.
The intended use of the body frame is patient fixation, localization and centering for radiotherapy treatments of tumoral lesions in the body. These functions are obtained by means of a fixation plate (the base plate) that is both connected to the patient (with thermoconformable mask or cushion) and to the LINAC couch.
Stereotactic Body Frame Cod. 70-1A is patient localization system for use in stereotactic radiosurgery. It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning and conduct of 3 dimensional radiation therapy.
Product codes
90 IYE
Device Description
Stereotactic Body Frame is a spatial reference system external to the body of a patient undergoing radiotherapy treatment that provides accurate positioning of the patient in spatial registration with diagnostic images and a radiotherapy treatment plan.
Material: Carbon-fiber and plexiglass
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT only
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUL 18 2003
PENDIX 6: 510 (K) SUMMARY
510(k) Summary As required by 807.92 For ERGO SRS Prepared on January 17, 2003
Submitted by: 3D Line USA, Inc. 11419 Cronridge Drive, Suite 15 Owings Mills, MD 21117
Tel. 410-581-6701
Fax: 410-581-9007
Contact Person: Nader Salehi Vice President
Device Trade Name: Stereotactic Body Frame
Common Name: Stereotactic patient positioning system
Classification: Medical charged-particle radiation therapy system, Class II Sec. 21 CFR 892.5050
Predicate Device: Stereotactic Body Frame, K960338
Manufactured by: Elekta Instrument AB, St. Larsgatan 8 S-582, Linkoping, Sweden
Description of the Device: Stereotactic Body Frame is a spatial reference system external to the body of a patient undergoing radiotherapy treatment that provides accurate positioning of the patient in spatial registration with diagnostic images and a radiotherapy treatment plan.
Intended Use for the Device: It is intended for use in the planning and conduct of 3 dimensional radiation therapy with a linear accelerator.
Substantial Equivalence to Predicate Device: 3D line's Stereotactic Body Frame is substantially equivalent to Elekta Instrument AB's Stereotactic Body Frame. A comparison of clinically relevant characteristics is given below.
1
Statement of Substantial Equivalence to Stereotactic Body Frame of Electa Instrument AB (K960338)
| Characteristics | Body Frame | Elekta Body Frame |
|---|---|---|
| Indication | ||
| (Intended Use & Device | ||
| Description) | The intended use of the body frame is | |
| patient fixation, localization and centering | ||
| for radiotherapy treatments of tumoral | ||
| lesions in the body. These functions are | ||
| obtained by means of a fixation plate (the | ||
| base plate) that is both connected to the | ||
| patient (with thermoconformable mask or | ||
| cushion) and to the LINAC couch. | Same intended use. | |
| Characteristics | Material: Carbon-fiber and plexiglass | |
| Image: Body Frame | Material: Plastic and | |
| aluminum | ||
| Image: Elekta Body Frame | ||
| Compatibility with software | Compatible with ERGO-SCT | Compatible with |
| commercially available | ||
| software planning. | ||
| Similarities in Design | ➤ Usage of reference system that is | |
| external to the patient's body | ||
| ➤ Usage of stereotactic coordinates to | ||
| reproduce the coordinates of a target in | ||
| both diagnostic and treatment | ||
| procedures | ||
| ➤ Copper indicators for determination of | ||
| targte coordinates on CT | ||
| ➤ Can be used for stereotactic | ||
| radiosurgery (SRS) or stereotactic | ||
| radiotherapy (SRT). | ||
| Differences in Design | ➤ To be used with CT only | |
| ➤ No arc ruler used, but a frame with | ||
| coordinates scales | ||
| ➤ Localization is achieved without | ➤ Can be used with CT | |
| and MRI |
:
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Image /page/2/Picture/1 description: The image shows a logo with a circular border. Inside the circle, there are three curved lines that resemble a bird in flight. The lines are thick and black, and they are arranged in a way that suggests movement. The logo is simple and abstract, and it is likely used to represent an organization or company.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2003
Mr. Nader Salehi Vice President 3D Line USA, Inc. 11419 Cronridge Drive Suite 15 OWINGS MILLS MD 21117
Re: K031631 Trade/Device Name: Stereotactic Body Frame Cod. 70-1A Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: April 14, 2003
Received: May 27, 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. Iisting 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 (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.
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Page 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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image is a logo with the text "3D LINE USA" stacked on top of each other. The "3D" is in a larger, bolder font and appears to be three-dimensional. The word "LINE" is smaller and placed below "3D", and "USA" is at the bottom, slightly offset to the right. The logo has a simple, geometric design and is in black and white.
Applicant: 3D Line USA. Inc.__
| 510(k) Number (if known): | K03163/1 |
|---|---|
| --------------------------- | ---------- |
Device Name: __Stereotactic Body Frame Cod. 70-1A ____________________________________________________________________________________________________________________________
Indications For Use:
Stereotactic Body Frame Cod. 70-1A is patient localization system for use in stereotactic radiosurgery. It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning and conduct of 3 dimensional radiation therapy.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Daniel A. Legnon
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devic 510(k) Number
Prescription Use
(Per 21 CFR 801.109)