(256 days)
Not Found
No
The description focuses on the device's function as a physical beam-shaping tool (Micro-Multi-Leaf-Collimator) and explicitly states that mentions of AI, DNN, or ML were "Not Found". The device operates based on pre-defined aperture parameters, not adaptive or learning algorithms.
Yes
The AccuLeaf is used in radiation therapy to deliver radiation to target volumes for treatment, which is a therapeutic purpose.
No
The document describes a device used in radiation therapy to shape the radiation beam, not to diagnose a medical condition.
No
The device description explicitly states it is composed of multiple hardware modules (MMLC module, LINAC interface module, Workstation, Distribution module) in addition to software (AccuLeaf-CS).
Based on the provided information, the AccuLeaf device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the AccuLeaf is used to assist in the delivery of radiation to patients during radiotherapy and radiosurgery. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a physical device that shapes a LINAC beam. This is a component of a radiation therapy system, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The AccuLeaf's function is to physically shape a radiation beam for therapeutic purposes.
N/A
Intended Use / Indications for Use
The AccuLeaf is intended to assist the radiation oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. The AccuLeaf enables irregular fields treatments to be performed with finely shaped patterns. In this application the AccuLeaf performs the same function as customized beam shaping blocks, and circular or cut blocks collimators, which have been used for many years
Product codes
90 IYE
Device Description
AccuLeaf is a LINAC based Micro-Multi-Leaf-Collimator (MMLC), used during both conformal stereotactic radiotherapy and conformal stereotactic radiosurgery. It enables shaping the LINAC beam according to tumor shape and clinical demands. The device is composed of the MMLC module, the LINAC interface module, the Workstation (with AccuLeaf-CS), and the Distribution module. The device is operated in conjunction with a LINAC, its treatment couch, a data file that contains the desired aperture parameters, and any additional equipment required during radiotherapy/ radiosurgery.
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
radiation oncologist
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 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
510(K) SUMMARY
AccuLeaf 510(k) Number Koz | 33 S
Applicant's Name:
Direx Systems Corp. 11 Mercer Road, Natick Business Park Natick, MA 01760 United States of America
Tel: (508) 6510900 Fax: (508) 6518125
Contact Person:
Larisa Gershtein Tel: (508) 6510900 Fax: (508) 6518125
Trade Name: AccuKnife
Model:
AccuLeaf
Classification Name:
Medical Linear Accelerator
Classification:
The FDA has classified this type of devices as class II (product code 90 IYE, Regulation No. 892.5050) and they are reviewed by the Radiology Panel.
1
Predicate Devices:
BrainLAB Med. GmbH's Micro-Multi Leaf Collimator (K970586)
Performance Standards:
No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. However, AccuLeaf complies with the following voluntary standards: IEC 60601-1 (1990) +A1 (1993) +A2 (1995); IEC 60601-1-1 (2000); IEC 60601-1-2 (1993); IEC 60601-1-4 (2000).
Intended Use:
The AccuLeaf is intended to assist the radiation oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
The AccuLeaf enables irregular fields treatments to be performed with finely shaped patterns. In this application the AccuLeaf performs the same function as customized beam shaping blocks, and circular or cut blocks collimators, which have been used for many years
Device Description:
AccuLeaf is a LINAC based Micro-Multi-Leaf-Collimator (MMLC), used during both conformal stereotactic radiotherapy and conformal stereotactic radiosurgery. It enables shaping the LINAC beam according to tumor shape and clinical demands. The device is composed of the MMLC module, the LINAC interface module, the Workstation (with AccuLeaf-CS), and the Distribution module. The device is operated in conjunction with a LINAC, its treatment couch, a data file that contains the desired aperture parameters, and any additional equipment required during radiotherapy/ radiosurgery.
Substantial Equivalence:
Based on validations and performance testing results, Direx Systems Corp. believes that AccuLeaf is substantially equivalent to the predicate device cited above without raising new safety and/or effectiveness issues.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 7 2003
Ms. Larisa Gershtein OA Manager DiREX Systems Corp. 11 Mercer Road NATICK MA 01760
Re: K021338 Trade/Device Name: AccuLeaf Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation system Regulatory Class: II Product Code: 90 IYE
Dated: October 7, 2002 Received: October 11, 2002
Dear Ms. Gershtein:
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 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
This letter will allow you to begin marketing your device as described in your 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 this 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" (21 CFR Part 807.97). 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 Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K021338
Device Name:
AccuLeaf
Indications for Use:
The AccuLeaf is intended to assist the radiation oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. The AccuLeaf enables irregular fields treatments to be performed with finely shaped patterns. In this application the AccuLeaf performs the same function as customized beam shaping blocks, and circular or cut blocks collimators, which have been used for many years
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
510(k) Number L021338
Prescription Use (Per 21 CFR 801.109)
OR
Over the Use
Counter
David A. Leymon
(Division Sign-Off Division of Reproductive, I and Radiological Devic 7-6 510(k) Number