(52 days)
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.
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.
The provided text is a 510(k) summary for the Stereotactic Body Frame, focusing on its substantial equivalence to a predicate device. It specifies the intended use and compares characteristics, but it does not contain information about studies proving the device meets specific acceptance criteria related to its performance.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size
- If a standalone study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document focuses on demonstrating substantial equivalence to a previously cleared device (Elekta Instrument AB's Stereotactic Body Frame, K960338) based on similarities in intended use, design, and materials, rather than presenting a performance study with acceptance criteria.
{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 & DeviceDescription) | The intended use of the body frame ispatient fixation, localization and centeringfor radiotherapy treatments of tumorallesions in the body. These functions areobtained by means of a fixation plate (thebase plate) that is both connected to thepatient (with thermoconformable mask orcushion) and to the LINAC couch. | Same intended use. |
| Characteristics | Material: Carbon-fiber and plexiglassImage: Body Frame | Material: Plastic andaluminumImage: Elekta Body Frame |
| Compatibility with software | Compatible with ERGO-SCT | Compatible withcommercially availablesoftware planning. |
| Similarities in Design | ➤ Usage of reference system that isexternal to the patient's body➤ Usage of stereotactic coordinates toreproduce the coordinates of a target inboth diagnostic and treatmentprocedures➤ Copper indicators for determination oftargte coordinates on CT➤ Can be used for stereotacticradiosurgery (SRS) or stereotacticradiotherapy (SRT). | |
| Differences in Design | ➤ To be used with CT only➤ No arc ruler used, but a frame withcoordinates scales➤ Localization is achieved without | ➤ Can be used with CTand MRI |
:
{2}------------------------------------------------
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.
{3}------------------------------------------------
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
{4}------------------------------------------------
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)
§ 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.