(89 days)
Not Found
No
The summary describes a mechanical drainage system and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the evacuation of hematomas and hygromas and the removal of fluid and air from the subdural space, which are therapeutic interventions.
No
The device is described as facilitating the evacuation and draining of fluid from the cranium, indicating a therapeutic or treatment-oriented function rather than a diagnostic one.
No
The device description explicitly lists physical components (EVAC Port, Tubing, Vacuum bulb) and mentions a Cranial Access Kit, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used to drain fluid from the subdural space within the cranium. This is a therapeutic or surgical intervention, not a diagnostic test performed on samples in vitro (outside the body).
- Device Description: The description details a system for creating negative pressure and draining fluid, consisting of a port, tubing, and vacuum bulb. This aligns with a drainage device, not a diagnostic assay or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
The device is designed for direct intervention on the patient's body to remove accumulated fluid, which falls under the category of a medical device used for treatment or management, not diagnosis.
N/A
Intended Use / Indications for Use
The EVAC is indicated to facilitate the evacuation of a chronic or subacute hematoma or hygroma in the cranium. The EVAC is intended for draining of fluid accumulated in the subdural space, including chronic or subacute hematomas and hygromas. The EVAC is also intended for removing air and fluid from the subdural space following open surgical procedures to remove subdural collections.
Product codes
JXG
Device Description
The Borvo EVAC System is intended for the drainage of subdural fluid accumulations. The EVAC System is designed to gradually drain fluid to an external reservoir by creating a low negative pressure in the subdural space. It consists of 3 components:
-
- EVAC Port (Ergo or Classic)
-
- Tubing
-
- Vacuum bulb
An optional Cranial Access Kit can be purchased with the EVAC System, or a commercially available Cranial Access Kit with a 5.31mm drill bit can be used.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranium, subdural space
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)
A high-level summary of the testing conducted to confirm the safety and efficacy of the Borvo EVAC System is as follows:
- Dimensional .
- Tensile
- Pull-Out Force .
- . Simulated Use
- Sterile Barrier/Packaging Testing .
- . Shelf Life
- Biocompatibility .
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
Not Found
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).
0
August 20, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Borvo Medical, Inc. Ming Cheng Chew Regulatory Consultant 2500 Old Middlefield Way, Suite E Mountain View. California 94043
Re: K241458
Trade/Device Name: Borvo EVAC System (Ergo); Borvo EVAC System (Classic) Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt And Components Regulatory Class: Class II Product Code: JXG Dated: May 22, 2024 Received: May 23, 2024
Dear Ming Cheng Chew:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 -S Digitally signed by Adam D. Pierce -S Date: 2024.08.20 14:37:29 -04'00'
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
2
Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241458
Device Name Borvo EVAC System (Ergo); Borvo EVAC System (Classic)
Indications for Use (Describe)
The EVAC is indicated to facilitate the evacuation of a chronic or subacute hematoma or hygroma in the cranium. The EVAC is intended for draining of fluid accumulated in the subdural space, including chronic or subacute hematomas and hygromas. The EVAC is also intended for removing air and fluid from the subdural space following open surgical procedures to remove subdural collections.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(k) Summary: K241458 1
1.1 Contact Information
Sponsor/Manufacturer
Borvo Medical Inc. 2500 Old Middlefield Way, Suite E Mountain View, CA 94043 Phone: 551-697-8927 Email: sthompson@borvomedical.com
Correspondent
Ming Cheng Chew Regulatory Consultant, ROM+ Phone: 763-232-3701 Email: mchew@rqmplus.com
Date: August 20, 2024
1.2 Device Information
| Name of Device: | Borvo EVAC System |
|---|---|
| Classification Name: | Central Nervous System Fluid Shunt and Components |
| Regulation Number: | 21 CFR 882.5550 |
| Regulatory Class: | II |
| Product Code: | JXG |
1.3 Predicate Device
Medtronic SEPS Cranial Access Kit (K042359)
1.4 Device Description
The Borvo EVAC System is intended for the drainage of subdural fluid accumulations. The EVAC System is designed to gradually drain fluid to an external reservoir by creating a low negative pressure in the subdural space. It consists of 3 components:
-
- EVAC Port (Ergo or Classic)
-
- Tubing
-
- Vacuum bulb
An optional Cranial Access Kit can be purchased with the EVAC System, or a commercially available Cranial Access Kit with a 5.31mm drill bit can be used.
5
INDICATIONS FOR USE 1.5
The EVAC is indicated to facilitate the evacuation of a chronic or subacute hematoma or hygroma in the cranium. The EVAC is intended for draining of fluid accumulated in the subdural space, including chronic or subacute hematomas and hygromas. The EVAC is also intended for removing air and fluid from the subdural space following open surgical procedures to remove subdural collections.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE 1.6 PREDICATE DEVICE
| Characteristic | Borvo EVAC System | Medtronic SEPS Cranial
Access Kit (K042349) |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for the for
drainage of subdural fluid
accumulations. | Same |
| Indication for Use | The EVAC is indicated to
facilitate the evacuation
of a chronic or subacute
hematoma or hygroma in
the cranium. The EVAC.
is intended for draining
of fluid accumulated in
the subdural space,
including chronic or
subacute hematomas and
hygromas. The EVAC is
also intended for
removing air and fluid
from the subdural space
following open surgical
procedures to remove
subdural collections | Use of the SEPS Cranial
Access Kit is indicated
when access to and
evacuation of a cranial
subacute or chronic
hematoma or hygroma is
necessary. The SEPS
Cranial Access Kit is
intended for drainage of
subdural fluid
accumulations such as
hygromas and chronic or
subacute hematomas to an
external suction reservoir.
The SEPS Cranial Access
Kit is also intended for
draining air and fluids from
the subdural space
immediately following
craniotomy procedures
performed to remove a
chronic or subacute
subdural hematoma. |
| Product Code | JXG | Same |
| Regulation | 21 CFR 882.5550 | Same |
| Components | Port | Same |
| Characteristic | Borvo EVAC System | Medtronic SEPS Cranial
Access Kit (K042349) |
| | Tubing
Vacuum Bulb
Cranial Access Kit | |
| Drill Bit
Compatibility | 5.31 mm | Same |
| Port Material | Titanium | Stainless Steel |
| Port ID Distal | 0.150 inches | 0.149 inches |
| Port ID Proximal | 0.160 inches | 0.149 inches |
| Port OD at threads | 0.241 inches | 0.236 inches |
| Port OD at barbs | 0.250 inches | 0.236 inches |
| Thread pitch | 0.75 mm | 0.75 mm |
| Port Wing
Configuration | Angular (Classic)
or Curvilinear (Ergo) | Angular |
| Tubing Material | Thermoplastic Elastomer | Silicone |
| Bulb Configuration | Jackson-Pratt Reservoir | Same |
| Sterile | Yes | Same |
| Single-use only | Yes | Same |
| Biocompatibility | ISO 10993-1 | Same |
Table 1-1: Device Comparison to the Predicate Device
6
K241458 Page 3 of 4
1.7 PERFORMANCE DATA
A high-level summary of the testing conducted to confirm the safety and efficacy of the Borvo EVAC System is as follows:
- Dimensional .
- Tensile
- Pull-Out Force .
- . Simulated Use
- Sterile Barrier/Packaging Testing .
- . Shelf Life
- Biocompatibility .
7
K241458 Page 4 of 4
1.8 SUBSTANTIAL EQUIVALENCE
Based on the same intended use, similar technological characteristics, and the summary of data submitted, the Borvo EVAC System is found to be substantially equivalent to the predicate device. Testing demonstrated the device safety and effectiveness as intended without raising new and different questions of safety and effectiveness.