(196 days)
K/DEN: Not Found
No
The summary describes a mechanical catheter for pressure measurement and drainage, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML mentions.
No
The device is indicated for measurement of intracranial pressure and drainage of CSF, which are diagnostic and supportive functions, not therapeutic.
Yes
Explanation: The device is indicated for direct measurement of intracranial pressure, which provides information about the patient's physiological state and aids in diagnosis or monitoring.
No
The device description clearly describes a physical catheter with lumens, a bladder/balloon, and a connection to a pressure transducer, indicating it is a hardware 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 diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Hummingbird H900DS and H800S catheters are designed for direct measurement of intracranial pressure and/or drainage of CSF within the subdural space. This is an in vivo procedure, meaning it's performed directly on a living patient, not on a sample taken from the patient.
- Intended Use: The stated intended use clearly describes a procedure performed within the body.
Therefore, the device falls under the category of a medical device used for monitoring and/or drainage, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The use of the Hummingbird H900DS Subdural Catheter is indicated for direct measurement of intracranial pressure and drainage of CSF in the subdural space.
The use of the Hummingbird H800S Subdural Catheter is indicated for direct measurement of intracranial pressure in the subdural space
Product codes
GWM, HCA
Device Description
The HS900DS device is a dual lumen catheter, the outer lumen is for drainage of CSF, the inner lumen is a gas filled path connected to a bladder/balloon. The bladder is inserted into the space where pressure is to be measured. The distal end of the gas filled lumen is connected to a pressure transducer, which provides a measurement of the pressure in the lumen. The H800S is similar to the H900DS except it only contains the pressure sensing lumen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
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
Not Found
§ 882.1620 Intracranial pressure monitoring device.
(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).
0
KII3088
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Submitted by: InnerSpace 1622 Edinger Ave. Suite C, Tustin CA 92780 Ph 714 259 7900 Fax 714 259 7999
Contact person: Don Bobo (dbobo@innerspacemedical.com)
Predicate 510K Device: K013705
510(k) Number Not assigned
Device Name Hummingbird Subdural H900DS (Drainage and ICP) Hummingbird Subdural - H800S (ICP only)
Trade names Hummingbird Subdural H900DS (Drainage and ICP) Hummingbird Subdural - H800S (ICP only)
Common Name Subdural Catheter
Classification: Short-term catheter
Class II ( Per 21 CFR Part 882.1620 Intracranial pressure monitoring device.)
Product Code GWM, HCA
Predicate Devices
K013705 InnerSpace, Inc (Tunneled catheter)
Submittal type 510-(k)
This submission adds an indication for use of the InnerSpace tunneled ventricular catheter used to measure ICP and drain CSF. The added indication is its use to measure intracranial pressure (ICP) and/or drain CSF in the subdural space. A second catheter without a drainage lumen used to measure ICP is also included.
MAY - 2 2012
1
Device Description
The HS900DS device is a dual lumen catheter, the outer lumen is for drainage of CSF, the inner lumen is a gas filled path connected to a bladder/balloon. The bladder is inserted into the space where pressure is to be measured. The distal end of the gas filled lumen is connected to a pressure transducer, which provides a measurement of the pressure in the lumen. The H800S is similar to the H900DS except it only contains the pressure sensing lumen.
Product Function
The Subdural catheter provides the ability to measure ICP in the subdural space and, in one model, provides the ability to also drain fluid that collects on the brain.
Pressure Sensing
ICP is sensed by Air Coupled Transduction, which is identical to that in the predicate device. In this system, the pressure in a partially filled sleeve bladder on the body of the catheter responds to Bolyle's law in accordance to PJV 1=P2V2 The pressure developed within the catheter is conveyed via a dedicated airline to an external pressure.
Validation
The models are substantially equivalent to the predicate tunneled catheters because they use the same physical characteristics, use the same pressure sensor which meets the requirements of AAMI NS28 1988 Intracranial Pressure Monitoring Devices and they allow external zeroing of pressure. They use the same materials. all of which have been shown to be biocompatible and to function well in the intended application.
Indications For Use
The use of the Hummingbird H900DS Subdural Catheter is indicated for direct measurement of intracranial pressure and drainage of CSF in the subdural space.
The use of the Hummingbird H800S Subdural Catheter is indicated for direct measurement of intracranial pressure in the subdural space
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Innerspace, Inc. % Mr. Don Bobo 1622 Edinger Ave. Ste. C. Tustin, CA 92780
MAY - 2 2012
Re: K113088
Trade/Device Name: Hummingbird Subdural H900DS & H800S Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: Class II Product Code: GWM, HCA Dated: April 3, 2012 Received: April 20, 2012
Dear Mr. Bobo:
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. 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.
3
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K113088
Device Name: Hummingbird Subdural H900DS & H800S
Indications for Use:
The use of the Hummingbird H900DS Subdural Catheter is indicated for direct measurement of intracranial pressure and/or drainage of CSF in the subdural space.
The use of the Hummingbird H800S Subdural Catheter is indicated for direct measurement of intracranial pressure in the subdural space.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
HUTTER TOE
Page 1 of _ l
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices.
KII3088
510(k) Number