(217 days)
No
The document describes a navigated suction device accessory that uses optical tracking markers for localization within an existing image-guided surgery system. There is no mention of AI or ML in the intended use, device description, performance studies, or key metrics. The "pre-calibration" refers to automatic recognition by the system, not an AI/ML process.
No
The device is described as an accessory to an image-guided surgery system, specifically a "navigated suction device." Its purpose is to locate the tip of the suction instrument during surgical procedures, not to provide therapy itself. It facilitates surgical procedures like tumor resection, but suctioning for tissue removal is a surgical act, not a therapeutic device function in this context.
No
This device is a surgical accessory (navigated suction device) used during cranial image-guided surgery, assisting in tumor and lesion resection. It helps locate the tip of the suction device within the surgical field, rather than diagnosing a condition.
No
The device is described as a "Disposable Pre-calibrated Suction" which is an accessory to a Cranial Image Guided Surgery System. The description explicitly mentions physical components like a "polycarbonate handle glued to suction tube" and "flat markers attached to the integrated tracking array," indicating it is a physical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Disposable Pre-calibrated Suction is an accessory for a Cranial Image Guided Surgery System. Its purpose is to be used as a navigated suction device during surgical procedures. It helps locate the tip of the suction instrument within the surgical field using the IGS system.
- Lack of Specimen Analysis: The device does not analyze any specimens taken from the patient's body. It is a surgical tool used directly on the patient during a procedure.
The description clearly indicates its use as a surgical instrument for suction and navigation within the body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
Disposable Pre-calibrated Suction is an accessory of the Cranial Image Guided Surgery System and intended to be used as a navigated suction device in any surgical procedure in which the use of the Cranial Image Guided Surgery System may be indicated.
Surgical example procedures include:
- · Cranial resection of tumors and other lesions
- · Resection of skull base tumors or other lesions
- · AVM Resection
Product codes
HAW
Device Description
Disposable Pre-calibrated Suction is an accessory of the Cranial IGS system and intended to be used as a navigated suction device in any surgical procedure in which the use of the Cranial IGS system may be indicated.
The Brainlab Disposable Suction is an accessory for the currently released and developed Brainlab optical IGS systems for cranial procedures. The device will be pre-calibrated, i.e. it will be automatically recognized by the system and is immediately ready to use. By tracking the flat markers attached to the integrated tracking array, the instrument and thereby position of the tip can be located by the Brainlab optical IGS systems for cranial procedures.
The device is intended for single short term invasive use on an individual patient during a single procedure. This invasive device is used for a short-term limited contact (
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
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January 29, 2021
Brainlab AG Chiara Cunico Manager Regulatory Affairs Olof-Palme-Str. 9 Munich, Bavaria 81829 Germany
Re: K201752
Trade/Device Name: Disposable Pre-calibrated Suction Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: December 28, 2020 Received: December 31, 2020
Dear Chiara Cunico:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201752
Device Name Disposable Pre-Calibrated Suction
Indications for Use (Describe)
Disposable Pre-calibrated Suction is an accessory of the Cranial Image Guided Surgery System and intended to be used as a navigated suction device in any surgical procedure in which the use of the Cranial Image Guided Surgery System may be indicated.
Surgical example procedures include:
- · Cranial resection of tumors and other lesions
- · Resection of skull base tumors or other lesions
- · AVM Resection
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
January 29, 2021
| General Information | |||||
|---|---|---|---|---|---|
| Manufacturer | Brainlab AG, Olof-Palme-Str. 9, 81829, Munich, Germany | ||||
| Establishment Registration | 8043933 | ||||
| Device Name | Neurological Stereotaxic Instrument | ||||
| Trade Name | Disposable Pre-calibrated suction | ||||
| Classification Name | Stereotaxic instrument | ||||
| Product Codes | HAW | ||||
| Regulation Number | 882.4560 | ||||
| Regulatory Class | II | ||||
| Panel | Neurology | ||||
| Predicate Devices and K | 1. K082060 Cranial ENT IGS System | ||||
| Numbers | 2. K092467 Disposable Stylet | ||||
| Manufacturer | Brainlab AG |
| Contact Information | |
|---|---|
| Primary Contact | Alternate Contact |
| Chiara Cunico | Regulatory Affairs Brainlab |
| Manager RA | Phone: +49 89 99 15 68 0 |
| Phone: +49 89 99 15 68 0 | Fax: +49 89 99 15 68 5033 |
| Email: chiara.cunico@brainlab.com | Email: regulatory.affairs@brainlab.com |
1. Indications for Use
Disposable Pre-calibrated Suction is an accessory of the Cranial Image Guided Surgery System and intended to be used as a navigated suction device in any surgical procedure in which the use of the Cranial Image Guided Surgery System may be indicated.
Surgical example procedures include:
- · Cranial resection of tumors and other lesions
- Resection of skull base tumors or other lesions
- AVM Resection
4
2. Device Description
Disposable Pre-calibrated Suction is an accessory of the Cranial IGS system and intended to be used as a navigated suction device in any surgical procedure in which the use of the Cranial IGS system may be indicated.
The Brainlab Disposable Suction is an accessory for the currently released and developed Brainlab optical IGS systems for cranial procedures. The device will be pre-calibrated, i.e. it will be automatically recognized by the system and is immediately ready to use. By tracking the flat markers attached to the integrated tracking array, the instrument and thereby position of the tip can be located by the Brainlab optical IGS systems for cranial procedures.
The device is intended for single short term invasive use on an individual patient during a single procedure. This invasive device is used for a short-term limited contact (