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.

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.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the InDiscal™ Digital Manometer:

Acceptance Criteria and Device Performance

The document describes the InDiscal™ Digital Manometer as a sterile, single-use device for dispensing fluids and monitoring pressure in vertebral discs during spinal procedures (discography). The submission is a 510(k) premarket notification, which aims to demonstrate substantial equivalence to legally marketed predicate devices.

The "acceptance criteria" in this context are not explicitly stated as numerical targets in a table, but rather implicitly defined by the successful completion of various verification and validation tests designed to demonstrate substantial equivalence to predicate devices and compliance with design inputs. The reported device performance is that it "passed all verification and validation tests."

Here's a summarized table based on the information provided:

Acceptance Criteria Category (Implicit)	Specific Test Conducted	Reported Device Performance
Mechanical Integrity	Ingress Protection	Passed
	Pressure Vessel	Passed
	Push Test	Passed
	Drop Test	Passed
	Molding Stress Relief Test	Passed
Electrical Safety & Performance	Burn-in Test	Passed
	Dielectric Strength	Passed
	Pre-EMC Testing: Accuracy Test	Passed
	Pre-EMC Testing: Functionality Test	Passed
	Radiated Emissions	Passed
	Electrostatic Discharge (ESD)	Passed
	Magnetic Immunity	Passed
	Radiated Immunity	Passed
	Post-EMC Testing	Passed
	Battery Life and Low Battery Alarm Test	Passed
Accuracy of Pressure Gauge	Accuracy testing (under normal and low battery conditions)	Passed
General Design Compliance	General testing (to verify compliance to design inputs)	Passed
Software Functionality	Software validation (under normal and low battery conditions)	Passed

Study Details

Here's a breakdown of the study-related information:

Sample sizes used for the test set and the data provenance:
- Sample Size: Not specified. The document only lists types of tests conducted (e.g., Ingress Protection, Accuracy testing, Software validation).
- Data Provenance: Not specified. Given the nature of the tests (mechanical, electrical, software), these would typically be conducted in a laboratory setting by the manufacturer (Baylis Medical Company Inc., based in Canada).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The listed tests (mechanical, electrical, software accuracy) typically rely on engineering specifications or reference standards, not expert clinical interpretation, to establish "ground truth."
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/None. The tests described are objective engineering and performance evaluations against predefined specifications, not subjective clinical assessments requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This type of study is specifically designed for evaluating diagnostic imaging systems or AI algorithms with human readers, which is not applicable to a digital manometer.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The listed tests (Mechanical, Electrical, Software, Accuracy, General) are inherently standalone performance evaluations of the device itself, without human interpretation in the loop. The "Accuracy testing of the pressure gauge" and "Software validation" are examples of standalone performance assessments.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for these tests would be objective engineering standards, calibrated reference instruments, and design specifications. For example, for "Accuracy testing," the ground truth would be the known pressure generated by a calibrated standard, and the device's reading would be compared against it. For "Electrical Testing," the ground truth would be established by relevant electrical safety standards (e.g., IEC standards).
The sample size for the training set:
- Not applicable/Not specified. This device does not appear to involve machine learning or AI that would require a "training set" in the conventional sense. The "software validation" refers to verifying that the device's embedded software functions as designed.
How the ground truth for the training set was established:
- Not applicable, as there is no apparent training set for an AI/ML algorithm. The ground truth for the software validation would be the software's design requirements and specifications.

Summary

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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 FluidDispensing Syringe	Atrion Medical ProductsInc.	K020333
Integra Accumeter	Integra TM PainManagement	K033739

Device Description

FEB 2 3 2511

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Indications for Use

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,

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InDiscal™ Digital Manometer

therefore, the market clearance of the InDiscal Digital Manometer through this 510(k) Premarket Notification.

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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.

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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

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Indications for Use

510(k) Number (if known):

Device Name: InDiscal™ Digital Manometer

Indications for Use:

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

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Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K162192

Regulation Number and Section

§ 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).