(1032 days)
K872369, preamendments device
Not Found
No
The description focuses on the physical components and control systems for delivering proton beam therapy, with no mention of AI or ML technologies.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use in the therapeutic application of a proton beam for the treatment of localized turnors or other diseases that are susceptible to treatment by radiation."
No
This device is used for therapeutic application (treatment of localized tumors with a proton beam), not for diagnosing conditions.
No
The device description explicitly lists hardware components like "beam delivery equipment" and "beam production equipment," in addition to the software components (TSS and TCS).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description and Intended Use: The description clearly states that this device is a facility designed to produce and deliver a proton beam for the treatment of patients with localized tumors or other diseases. It focuses on the therapeutic application of radiation directly to the patient's body.
- Lack of Specimen Examination: There is no mention of examining specimens from the human body in vitro. The device interacts directly with the patient.
Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Northeast Proton Therapy Center ("NPTC") is a facility designed to produce and deliver a proton beam of known energy, intensity and shape for treatment of a patient. It is indicated for use in the therapeutic application of a proton beam for the treatment of localized turnors or other diseases that are susceptible to treatment by radiation. The facility is designed so that it will: (1) create and direct (deliver) the proton beam appropriately to the patient treatment location: (2) produce a transverse and longitudinal dose distribution appropriate for the patient treatment; and (3) deliver the designated dose to the patient's treatment site.
Product codes (comma separated list FDA assigned to the subject device)
90 LHN
Device Description
The equipment installed in the NPTC is comprised of the following two main components: (1) the beam delivery equipment and (2) the beam production equipment. The primary responsibility of the beam delivery equipment is to direct the proton beam to the patient's treatment site within the patient treatment location and to ensure that the patient critical functions are properly and safely carried out. The beam production equipment is necessary to produce the proton beam and direct it to the appropriate treatment room. In addition to the main components, the equipment in the NPTC also includes: (1) a Therapy Safety System ("TSS"); and (2) a computer-based Therapy Control System ("TCS").
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)
The submission includes performance testing that Massachusetts General Hospital conducted to demonstrate that the device meets its performance specifications.
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.
K872369, preamendments device
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.
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
JUL 2 0 2001
983332
510(k) SUMMARY Massachusetts General Hospital Northeast Proton Therapy Center
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004-1109
Phone: (202) 637-5794 Facsimile: (202) 637-5910
Contact Person: same as above
September 21, 1998 Date Prepared:
Name of Device and Name/Address of Sponsor
Northeast Proton Therapy Center
Massachusetts General Hospital Northeast Proton Therapy Center 30 Fruit Street Boston, MA 02114
Classification Name
Medical Charged-Particle Radiation Therapy System (21 C.F.R. § 892.5050)
Predicate Devices
- Loma Linda University Medical Center's Proton Beam Therapy Center (1) (K872369)
- Harvard University Cyclotron Laboratory's Proton Beam Therapy (2) Center (preamendments device)
Intended Use
The Northeast Proton Therapy Center ("NPTC") is a facility designed to produce and deliver a proton beam of known energy, intensity and shape for treatment of a patient. It is indicated for use in the therapeutic application of a
DC - 57171/5 - 0363497.07
1
proton beam for the treatment of localized turnors or other diseases that are susceptible to treatment by radiation. The facility is designed so that it will: (1) create and direct (deliver) the proton beam appropriately to the patient treatment location: (2) produce a transverse and longitudinal dose distribution appropriate for the patient treatment; and (3) deliver the designated dose to the patient's treatment site.
Technological Characteristics
The equipment installed in the NPTC is comprised of the following two main components: (1) the beam delivery equipment and (2) the beam production equipment. The primary responsibility of the beam delivery equipment is to direct the proton beam to the patient's treatment site within the patient treatment location and to ensure that the patient critical functions are properly and safely carried out. The beam production equipment is necessary to produce the proton beam and direct it to the appropriate treatment room. In addition to the main components, the equipment in the NPTC also includes: (1) a Therapy Safety System ("TSS"); and (2) a computer-based Therapy Control System ("TCS").
Substantial Equivalence Discussion
The NPTC is substantially equivalent to both the Loma Linda (K872369) and the Harvard Cyclotron Laboratory proton therapy devices, the latter of which is a preamendments device. Like its predicate devices, the NPTC is a facility designed to produce and deliver a proton beam of known energy, intensity and shape for treatment of a patient. It is indicated for use in the therapeutic application of a proton beam for the treatment of localized tumors or other diseases that are susceptible to treatment by radiation.
The NPTC and its predicate devices provide the same or substantially equivalent functions, characteristics, and accessories as the NPTC. All of these devices are comprised of beam delivery systems that shape, direct, and monitor the protons delivered to the patient. They are also comprised of beam production equipment that generates the beam used by the beam delivery systems. All of the facilities include patient treatment rooms, but each has a different number of rooms.
The beam range in both the NPTC and Loma Linda facilities is similar. Even though the NPTC and its predicate devices use different accelerators. the engineering principles underlying their design are the same. The safety and control systems for the NPTC, Loma Linda, and HCL facilities are equivalent.
Although there are some differences between the NPTC and its predicate devices, these differences are minor and raise no new questions of safety and effectiveness.
2
Performance Data
The submission includes performance testing that Massachusetts General Hospital conducted to demonstrate that the device meets its performance specifications.
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 0 2001
Massachusetts General Hospital % Mr. Jonathan S. Kahan Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, NW WASHINGTON DC 20004-1109 Re: K983332
Northeast Proton Therapy Center (Proton Therapy Center) Dated: June 4, 2001 Received: June 5, 2001 Regulatory Class: II 21 CFR 892.5050/Procode: 90 LHN
Dear Mr. Kahan:
Down has a market to a finent to market the device referenced above and we have deemning the We have reviewed your Section 5 (1){ } houtleation of much onclosure) to legally marketed prochisat devices
device is substantially equivalent (for the indications of the enc device is substantially equivalent (of the macantist to tas sation and the Medical Device Amendments, or to devices of to devices of to devices of to devices of to devices of marketed in interstate commerce prior of the Federal Food, Drug, and Comments Act (Act.). Tou may,
that have been reclassified in accordance with the provisions of the are that have been reclassified in accordance will the provisions of the reason on the provisions of the Act .
therefore, market the device, subject to the general controls provi therefore, market the device, subject of the general controls of the rear magazine of the ground of the mainst misbranding and adulteration.
If your device is classified (see above) into either class II (Premaket Approval), it may be subject If your device is classified (see above) into ellier coass of (optude control in the Code of Federal Regulations, to such additional controls. Existing major regulations arectives with the Current Good Manufacturing
Title 21, Parts 800 to 895. A substantialiy equivalent decembriation C Title 21, Parts 800 to 895. A substantialion (QS) for Medical Devices: General regulation (21 CFR Part
Practice requirements, as set forth in the Qualine (Device (DVA) Vecif Practice requirements, as set forth in the Qualified (40) for and Drup (402) will bently such assumptions. Failure
820) and that, through periodic QS inspections, the Food an 820) and that, through periodic QS inspections, the Programs Program Prohish further announcements
to comply with the GMP regulation may result in regulatory action. In acce to comply with the GMP regulation may result in regulations on more notification sumission doss not
concerning your device in the Federal Register. Please not of the Alectio concerning your device in the Federal Register. Ticase noter in the respections under the Electronic Product arroot any obtigations, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in the PDA finding for your device and This letter will allow you to begally marketing your device to real procession 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 01 and additionally for questions on the promotions on the promotions on the promotions If you desire specific advice to your device of Compliance at (301) 584-4639. Additionally, for questions on the promotion diagnostic devices), please contact the Office of Compliation in (301) 594-4639. Also, please not the regulation of version of version on version on version on version on ve entitled, "Misbranding by reference to premarket notification". Other general information on your a entitled, "Misbranding by reterence to premaint notine of Sconel Manufactures assistance at its toll-free number (800)
responsibilities under the Act may be obtained from the responsibilities under the Act may be oblamed from the Drilston of Birlines of Suites
638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsma
Sincerely yours,
Nancy Crogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
4
510(k) Number (if known): 1 98 333 Z
Device Name:
Northeast Proton Therapy Center
Indications for Use:
The NPTC is a facility intended to produce and deliver a proton beam of known The NPTC is a factify intended to product of a patient. It is indicated for use in the energy, intensity and shape for treatment or a parcelor of I localized tumors or
therapeutic application of a proton beam for the treatment of the facility is ther diseases that are susceptible to treatment by radiation. The facility is
other diseases that are susceptible to treatment by proton heam other diseases that are susceptions to dreated direct (deliver) the proton beam designed so that it will. (1) create and includes a transverse and appropriately to the patient Libaton locator, (or process treatment; and (3) deliver
longitudinal dose distribution appropriate for the patient treatment; and (3) deliver the designated dose to the patient's treatment site.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluations (ODE)
| Prescription Use | OR | Over-the-Counter Use |
|---|---|---|
| ------------------ | ---- | ---------------------- |
(Per 21 C.F.R. 801.109)
(Optional Format 1-2-96)
(Division Sign-Off) Division of Reproductive, Abd and Radiological Devices 510(k) Number .
\DC . 57171/5 . 0383487.08