(170 days)
Leksell Gamma Knife® Perfexion™ is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g. metastatic tumors, arteriovenous malformations, trigeminal neuralgia, medically refractory essential tremor, meningiomas, post-surgical pituitary adenomas and recurrent glioblastomas.
Leksell Gamma Knife Perfexion is a radiosurgery system for use in the stereotactic irradiation of intra-cranial structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.
Based on preoperative radiological examinations, the Leksell Gamma Knife Perfexion unit provides highly accurate external irradiation of intra-cranial structures using collimated beams of ionizing radiation.
Each unit contains 192 sealed sources of Cobalt 60.
Leksell Gamma Knife Perfexion systems consists of several units, physically separated in an Office side in the control room and a Medical side in the treatment room.
- The medical side consists basically of the radiation unit with a patient positioning . system. The system control and power units are placed inside the cover of the radiation unit.
- The office side consists of the operator console with control panel and office computer. .
This device, the Leksell Gamma Knife® Perfexion™, is a medical device for stereotactic radiosurgery. The provided documentation is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a de novo study with explicit acceptance criteria for a novel device.
Therefore, the typical acceptance criteria and study design for proving performance in the context of a new device are not directly applicable here. Instead, the "study" that proves the device meets the acceptance criteria is the demonstration of substantial equivalence to its predicate device (K120811). The acceptance criteria for this type of submission are implicitly that the new device is as safe and effective as the predicate and shares fundamental technical characteristics.
Here's an attempt to structure the information based on your request, highlighting where the traditional study components are not directly present or are addressed through literature review and comparison:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance |
|---|---|
| Safety: Device is as safe as the predicate device (K120811). | A risk analysis review was performed, confirming no changes to safety assessments. The device is concluded to be as safe as its predicate. |
| Effectiveness: Device is as effective as the predicate device (K120811) for its intended use. | A clinical literature review was conducted to support the safety and efficacy for new indications (essential tremor, pituitary adenomas, glioblastoma). Scientific advisors found extensive publications. The device is concluded to be as effective as its predicate. |
| Fundamental Technical Characteristics: Device shares fundamental technical characteristics with the predicate device (K120811). | The fundamental technical characteristics are stated to be the same as those of the predicate device. |
| New Indication Support: Safety and efficacy for added indications (essential tremor, pituitary adenomas, glioblastoma) are supported. | Clinical literature review and approval by physicians regarding clinical relevance based on previous models. Extensive scientific publications support expanded indications. |
Further Details on the "Study" and Ground Truth Establishment
-
Sample size used for the test set and the data provenance:
- No explicit "test set" in the traditional sense of a new clinical trial was used.
- The "test set" information for demonstrating safety and effectiveness relied on a clinical literature review. The provenance of this data would be from various scientific publications, likely international, covering retrospective and prospective studies performed with Gamma Knife technology (including previous models and the predicate device).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document mentions that "scientific advisors found extensive scientific publications" and "reports have been approved by physicians regarding clinical relevance, based on experience of previous models of the system."
- The number of experts is not specified.
- Their qualifications are generally described as "physicians" and "scientific advisors" with experience in the field of stereotactic radiosurgery and Gamma Knife systems. Specific years of experience (e.g., "radiologist with 10 years of experience") are not provided.
-
Adjudication method for the test set:
- Not applicable in the context of a literature review. The "adjudication" was effectively through peer review of published scientific literature and the internal review and acceptance by the notifying company's scientific advisors and physicians.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, a MRMC comparative effectiveness study was not explicitly done for this 510(k) submission. The submission relies on demonstrating equivalence to the predicate device and literature review for new indications, not a direct comparison of human readers with vs. without AI assistance (as this is a treatment device, not an diagnostic AI).
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not explicitly applicable. The Leksell Gamma Knife Perfexion is a complete radiosurgery system, not a standalone algorithm. Its performance is inherent to the system delivering radiation based on a treatment plan, which involves human input (e.g., physicians defining targets). The "performance" assessment focuses on the system's ability to safely and effectively deliver radiation as prescribed, consistent with its predicate.
-
The type of ground truth used:
- For the demonstration of safety and effectiveness, the "ground truth" was derived from:
- Clinical outcomes data reported in the scientific literature for treatments performed with Leksell Gamma Knife systems (including previous models and the predicate).
- Expert consensus among physicians and scientific advisors regarding the clinical relevance and safety/efficacy based on existing knowledge and literature.
- Risk analysis review for safety, which serves as a form of internal validation against established safety standards.
- For the demonstration of safety and effectiveness, the "ground truth" was derived from:
-
The sample size for the training set:
- Not applicable in the context of a 510(k) submission for a physical device, as there isn't a "training set" for an algorithm in the traditional sense here. Any "training" for the device's development would be part of engineering and design validation, not typically reported with a sample size like for an AI model.
-
How the ground truth for the training set was established:
- Not applicable for the same reasons as above. The device's underlying physics and engineering principles are established, and its performance is validated against these principles and against the performance of the predicate device, not through an algorithm's training set as in AI.
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MY 0 9 2014
K133565
Page 1 of 3
Dokumentnamn/Name of document
ELEKTA INSTRUMENT AB
Traditional 510(k)
| Utfärdare/Issuer | Matilda Forsberg |
|---|---|
| Ref nr/Dok nr/Ref no/Doc no | -- |
| Utgava /Edition | -- |
| Avser/Regarding | Leksell Gamma Knife Perfexion |
| Directory | -- |
Section 4- 510(k) Summary
As Required by 21 CFR 807.92(c) 510 (k) Summary
Subscribers Name & Address 1.
Elekta Instrument AB Kungstensgatan 18, P.O. Box 7593 SE-103 93 Stockholm, Sweden Tel: (011) 46 8 587 254 00 Fax: (011) 46 8 587 255 00 Official Correspondent: Ms Louise Wachtmeister
Date summary prepared: 2013-11-14
2. Trade Name
Leksell Gamma Knife® Perfexion™
Device Classification 3.
| Common Name | Product Code | Class | Regulation Number |
|---|---|---|---|
| Leksell Gamma Knife® Perfexion™ | IWB | II | 21 CFR 892.5750 |
Predicate Device Identification 4.
| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|---|---|
| Leksell Gamma Knife® Perfexion ™™ | K120811 |
5. Other relevant submissions
| Devices | 510(k) # |
|---|---|
| Leksell Stereotactic System | K080355 |
| Leksell GammaPlan® PFX | K103093 |
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ELEKTA INSTRUMENT AB
Dokumentnamn/Name of document Traditional 510(k)
| Utfärdare/IssuerMatilda Forsberg | Ref nr/Dok nr/Ref no/Doc no-- | Utgåva /Edition-- |
|---|---|---|
| Avser/Regarding:Leksell Gamma Knife Perfexion | -- | Directory-- |
Device Description 6.
Leksell Gamma Knife Perfexion is a radiosurgery system for use in the stereotactic irradiation of intra-cranial structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.
Based on preoperative radiological examinations, the Leksell Gamma Knife Perfexion unit provides highly accurate external irradiation of intra-cranial structures using collimated beams of ionizing radiation.
Each unit contains 192 sealed sources of Cobalt 60.
Leksell Gamma Knife Perfexion systems consists of several units, physically separated in an Office side in the control room and a Medical side in the treatment room.
- The medical side consists basically of the radiation unit with a patient positioning . system. The system control and power units are placed inside the cover of the radiation unit.
- The office side consists of the operator console with control panel and office computer. .
7. Intended Use
Leksell Gamma Knife® Perfexion™ is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters. Indications include but are not limited to; metastatic tumors, arteriovenous malformations, trigeminal neuralgia, essential tremor, meningiomas, vestibular schwannomas, pituitary adenomas and glioblastoma.
8. Nonclinical testing
Non-clincal testing was not required to support substantial equivalence with the predicate device. The fundamental technical characteristics are the same to those of the predicate device.
A risk analysis review was performed to check the impact from the new intended use. The investigation resulted in no changes to any assessments regarding the safety of the Leksell Gamma Knife® Perfexion. The conclusion was that the Leksell Gamma Knife® Perfexion is as safe and as effective as its predicate for the new indications.
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A INSTRUMENT AR
ELEKTA INSTRUMENT AB
Traditional 510(k)
| Utfärdare/Issuer | Matilda Forsberg |
|---|---|
| Ref nr/Dok nr/Ref no/Doc no | -- |
| Utgåva /Edition | -- |
| Avser/Regarding | Leksell Gamma Knife Perfexion |
| Directory | |
| -- |
Dokumentnamn/Name of docume
9. Summary of clinical tests
A clinical literature review was conducted to demonstrate that the Leksell Gamma Knife® Perfexion is safe and effective for the new indications added to the intended use. Reports have been approved by physicians regarding clinical relevance, based on experience of previous models of the system.
The scientific advisors found extensive scientific publications supporting the safety and efficacy of using Leksell Gamma Knife Perfexion for the added indications (essential tremor, pituitary and glioblastoma).
10. Substantial Equivalence
The functionality for the Leksell Gamma Knife Perfexion is equivalent to its predicate device K120811 in safety and effectiveness and the fundamental technical characteristics are the same to those of the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The central symbol resembles a stylized bird or abstract shape with three curved lines forming its body and wing.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 9, 2014
Elekta Instrument AB % Ms. Matilda Forsberg Regulatory Affairs Engineer Kungstensgatan 18 SE-103 93 Stockholm SWEDEN
. Re: K133565
Trade/Device Name: Leksell Gamma Knife® Perfexion™ Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: IWB Dated: April 16, 2014 Received: April 28, 2014
Dear Ms. Forsberg:
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 cnacument 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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-Ms. Forsberg
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Smh.7)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K133565
Device Name Leksell Gamma Knife Perfexion
Indications for Use (Describe)
Leksell Gamma Knife® Perfexion™ is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g. metastatic tumors, arteriovenous malformations, trigeminal neuralgia, medically refractory essential tremor, meningiomas, post-surgical pituitary adenomas and recurrent glioblastomas.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
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| FOR FDA USE ONLY | |
|---|---|
| Call Concession Company Control Concession |
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
h.7)
FORM FDA 3881 (6/13)
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§ 892.5750 Radionuclide radiation therapy system.
(a)
Identification. A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.(b)
Classification. Class II.