(203 days)
Not Found
No
The description focuses on mechanical and electrical components, and the performance studies are standard engineering and software validation tests, with no mention of AI/ML algorithms or data sets.
No.
The device dispenses fluids and monitors pressure but does not treat the suspected intervertebral disc pathology; it is an accessory to a diagnostic procedure (discography).
No
The device is used to dispense fluids and monitor pressure during a diagnostic procedure (discography), but it does not diagnose the pathology itself. It provides data (pressure readings) that a qualified healthcare professional would interpret to make a diagnosis.
No
The device description explicitly states it consists of physical components like a syringe, plunger, palm grip, manometer with a digital LCD screen, and a connecting tube, indicating it is a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is used for dispensing fluids into the intervertebral disc and monitoring pressure during a medical procedure (discography). This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description focuses on the mechanical and electrical components used for fluid delivery and pressure measurement within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) outside the body, which is the defining characteristic of an IVD.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates directly within the body during a procedure.
N/A
Intended Use / Indications for Use
The InDiscal™ Digital Manometer is indicated to be used for dispensing fluids into the intervertebral disc and monitoring the pressure of those fluids during discography procedures in symptomatic patients with suspected intervertebral disc pathology.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The InDiscal™ Digital Manometer is a sterile, single-use device that is used to dispense fluids into and monitor pressure in vertebral discs during spinal procedures such as discography. The device consists of a plastic syringe with a screw-type plunger and locking lever, a rotating palm grip that controls the plunger, a manometer with a digital LCD screen and a connecting tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intervertebral disc
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)
Mechanical Testing:
- Ingress Protection
- Pressure Vessel
- Push Test
- Drop test
- Molding Stress Relief Test
Electrical Testing:
- Burn-in Test
- Dielectric Strength
- Pre-EMC Testing: Accuracy Test
- Pre-EMC Testing: Functionality Test
- Radiated Emissions
- Electrostatic Discharge (ESD)
- Magnetic Immunity
- Radiated Immunity
- Post-EMC Testing
- Battery Life and Low Battery Alarm Test
Accuracy testing of the pressure gauge was performed in order to demonstrate the accuracy of the InDiscal Digital Manometer under normal and low battery voltage conditions.
General testing was performed to verify compliance of the InDiscal Digital Manometer to design inputs.
Software validation was performed under normal and low battery voltage conditions.
The InDiscal Digital Manometer passed all verification and validation tests.
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.
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
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
Baylis Medical Company
6. 510(k) Summary
Submitter Information
A. Company Name: Baylis Medical Company Inc.
B. Company Address: 2645 Matheson Blvd. East Mississauga, Ontario L4W 5S4 Canada
C. Company Phone: (905) 602-4875; ext 252
D. Company Facsimile: (905) 602-5671
- E. Contact Person: Meghal Khakhar
- F. Summary Prepared on: July 27, 2010
Device Identification
- A. Device Trade Name: InDiscal™ Digital Manometer
- B. Device Common Name: Piston Syringe Discography Device
- C. Classification Name: 21 CFR 880.5860
- D. Device Class: Class II
- E. Device Code: FMF
Identification of Predicate Device
| Device name | Manufactured by | 510(k) number |
|---|---|---|
| Atrion Medical QLTM Fluid | ||
| Dispensing Syringe | Atrion Medical Products | |
| Inc. | K020333 | |
| Integra Accumeter | Integra TM Pain | |
| Management | K033739 |
Device Description
The InDiscal™ Digital Manometer is a sterile, single-use device that is used to dispense fluids into and monitor pressure in vertebral discs during spinal procedures such as discography. The device consists of a plastic syringe with a screw-type plunger and locking lever, a rotating palm grip that controls the plunger, a manometer with a digital LCD screen and a connecting tube.
FEB 2 3 2511
1
Indications for Use
The InDiscal™ Digital Manometer is indicated to be used for dispensing fluids into the intervertebral disc and monitoring the pressure of those fluids during discography procedures in symptomatic patients with suspected intervertebral disc pathology.
Substantial Equivalence
The intended use of the InDiscal™ Digital Manometer is substantially equivalent to the intended use of the Integra Accumeter and the design of the Atrion Medical OL™ Fluid Dispensing Syringe predicate devices. The following verification tests have been conducted in order to demonstrate substantial equivalence to the predicate devices.
Mechanical Testing
- Ingress Protection .
- . Pressure Vessel
- . Push Test
- . Drop test
- Molding Stress Relief Test ●
Electrical Testing
- . Burn-in Test
- Dielectric Strength .
- Pre-EMC Testing: Accuracy Test .
- ◆ Pre-EMC Testing: Functionality Test
- . Radiated Emissions
- ◆ Electrostatic Discharge (ESD)
- . Magnetic Immunity
- . Radiated Immunity
- Post-EMC Testing
- Battery Life and Low Battery Alarm Test .
Accuracy testing
Accuracy testing of the pressure gauge was performed in order to demonstrate the accuracy of the InDiscal Digital Manometer under normal and low battery voltage conditions.
General testing
General testing was performed to verify compliance of the InDiscal Digital Manometer to design inputs.
Software validation
Software validation was performed under normal and low battery voltage conditions.
The InDiscal Digital Manometer passed all verification and validation tests. The data and information presented in this application support a determination of substantial equivalence and,
2
InDiscal™ Digital Manometer
therefore, the market clearance of the InDiscal Digital Manometer through this 510(k) Premarket Notification.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Meghal Khakhar Manager, Regulatory Scientific Affairs Baylis Medical Company. Incorporated 2645 Matheson Boulevard East Mississauga, Ontario CANADA L4W S4
FEB 2 3 201
Re: K102192
Trade/Device Name: InDiscal™ Digital Manometer Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: February 15, 2011 Received: February 16, 2011
Dear Ms. Khakhar:
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.
4
Page 2- Mr. Khakhar
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 statures 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 (OS) 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/ucm l 15809.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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Jams I Fes
Fez
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices
Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510(k) Number (if known):
Device Name: InDiscal™ Digital Manometer
Indications for Use:
The InDiscal™ Digital Manometer is indicated to be used for dispensing fluids into the intervertebral disc and monitoring the pressure of those fluids during discography procedures in symptomatic patients with suspected intervertebral disc pathology.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lijd U for ic RZC feb 23, 2011
Page 1 of 1_________________________________________________________________________________________________________________________________________________________________
Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K162192