The AutoDetect Syringe is a spring loaded, loss of resistance syringe used during epidural anesthetic procedures. The device is intended for single-use only.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the AutoDetect Syringe.

It's important to note that the provided 510(k) summary is very brief regarding detailed study results. The information available points to a pre-market notification for a Class II device, which often relies on demonstrating substantial equivalence to a predicate device rather than extensive clinical efficacy trials involving human readers or ground truth establishment in the same way an AI-powered diagnostic device would.

Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Criteria	Reported Device Performance
Biocompatibility	Conformance to ISO 10993-1	The AutoDetect Syringe conforms to ISO 10993-1.
Syringe Performance	Conformance to ISO 7886-1	The AutoDetect Syringe conforms to ISO 7886-1.
Loss of Resistance (in-vitro/in-vivo simulation)	Not explicitly stated (implied to effectively demonstrate loss of resistance for epidural space verification)	The AutoDetect Syringe effectively demonstrates loss of resistance in in-vitro and in-vivo simulation testing, meeting performance specifications for its intended use.
Safety and Effectiveness	Safe and effective for its intended use (verification of needle tip placement in the epidural space)	The device is deemed safe and effective for its intended use.
Substantial Equivalence	To be substantially equivalent to predicate devices (Current Syringe (K001731) and B-D EPILOR LOR Syringe (K925902))	The device has been shown to be substantially equivalent to the currently marketed predicate devices in terms of intended use, product, performance, and biocompatibility.

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified. The document only mentions "in-vitro and in-vivo simulation testing" for loss of resistance. It does not provide specific numbers for patients or an in-vitro experimental setup.
- Data Provenance: Not specified. Given the nature of the device (a mechanical syringe) and the context of a 510(k) for a Class II device, the "in-vivo simulation" would likely refer to animal models or cadaver studies, though this is not explicitly stated. It is not clear if human data was used for testing.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not Applicable. This device is a mechanical syringe, not an AI/diagnostic imaging device where expert ground truth establishment for a test set in the traditional sense would be required. The "ground truth" for its performance would be its ability to consistently demonstrate a "loss of resistance" in a controlled environment or simulation, as evaluated by engineers or medical professionals operating the device in the test.
Adjudication Method for the Test Set:
- Not Applicable. As this is a mechanical device, there is no "adjudication method" for interpreting results in the way there would be for an AI diagnostic output. Performance would be assessed against engineering specifications and functional testing.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study is not relevant for this type of mechanical device. This device is a physical tool, not an AI to assist human "readers." The "convenience" offered by the spring-loaded plunger is stated to allow one-handed use, which is a qualitative benefit to the user experience, not an improvement in diagnostic accuracy for a "reader."
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a mechanical device, not an algorithm. There is no AI component.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" relates to the device's functional performance:
  - Biocompatibility: Conformance to ISO 10993-1 standards (chemical/material testing).
  - Syringe Performance: Conformance to ISO 7886-1 standards (mechanical and functional testing of the syringe).
  - Loss of Resistance: Reliable detection of the "loss of resistance" phenomenon in simulated environments (in-vitro/in-vivo). The "ground truth" here is the physical phenomenon itself, not an expert medical interpretation.
The Sample Size for the Training Set:
- Not Applicable. As a mechanical device without an AI component, there is no "training set."
How the Ground Truth for the Training Set was Established:
- Not Applicable. There is no "training set" for this mechanical device.

Summary

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510(k) Summary of Safety and Effectiveness

This summary of 510(k)-safety and effectiveness information is being submitted in This Summary of OTO(A) Canadala 1990 and 21 CFR 807.92.

Date Prepared: June 17, 2004

510(k) number: _______________________________________________________________________________________________________________________________________________________________

Applicant Information:

indiao orb, inc. 2355 Calle de Luna Santa Clara, CA 95054

Contact Person

Name:	Satish Sundar
Phone Number:	(408) 674-1580
Fax Number:	(408) 969-1932

Device Information:

Classification:	Class II
Trade Name:	AutoDetect Syringe
Classification Name:	Piston Syringe
Regulation Number:	21CFR 880.5860
Product Code:	FMF

Device Description:

The AutoDetect Syringe is a spring loaded, loss of resistance syringe used during epidural anesthetic procedures. The device is intended for single-use only.

Intended Use:

The AutoDetect Syringe is intended for use with an epidural needle for the verification of needle tip placement in the epidural space.

Equivalent Device:

The subject device is substantially equivalent in intended use and/or method of The Subjoct to not is Current Syringe (K001731) and the B-D EPILOR LOR Syringe (K925902).

Like the predicate syringes, The AutoDetect Syringe provides a means for detecting entry into the epidural space using the "loss of resistance" technique. All the devices are low friction piston syringes constructed of commonly used polymeric materials, such as polypropylene, silicone and polycarbonate.

The only difference between the AutoDetect Syringe and the identified predicate devices is that the plunger in the AutoDetect Syringe is lightly spring loaded. This convenience is that the plangor in the use one hand, as opposed to the two required in the currently used procedure, to identify entry into the epidural space.

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Test Results:

Test Results.
Biocompatibility testing to ISO 10993-1, syringe performance testing to ISO 7086-1 and Blocompatibility testing to 100 10000 1, cy of on the AutoPetect Syringe. Results
in-vitro and in-vivo simulation testing were performed on the AutoPetitions in-vitio and in-WV Simulation testing were performed on the serformance specifications and is safe and effective for its intended use.

Summary: Based on the intended use, product, performance and biocompatibility Summary. "Dased on this notification, the subject device has been shown to be imormation provided in the currently marketed predicate devices.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle with its wings spread.

JUN 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Indigo Orb, Incorporated C/O Mr. Morten Simon Christensen Responsible Third Party Official Underwriters Laboratories, Incorporated 1655 Scott Boulevard Santa Clara, California 95050-4169

Re: K041590

Trade/Device Name: AutoDetect Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: June 9, 2004 Received: June 14, 2004

Dear Mr. Christensen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because mined 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendments, or to arrived Cosmetic Act (Act) that do not require approval of a premarket the Federal F 600, Drag, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions or annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Wry, it nay of bund in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be fourther announcements concerning your device in the Federal Register.

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Page 2 - Mr. Christensen

Please be advised that FDA's issuance of a substantial equivalence determination does not r least that FDA has made a determination that your device complies with other requirements Incall that I DA mas mace a autos and regulations administered by other Federal agencies.

You must comply with all the Act's requirements, including, but not limited to: registration 1 ou must compry with are and many (21 CFR Part 801); good manufacturing practice allo listing (21 OF rear 801), eguality systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality and control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

21 CFN 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you over substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at no to: Joiance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chos L

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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112 Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The AutoDetect Syringe is intended for use with an epidural needle for the The AutoDetect Oynnige of the epidural space.

Prescription Use __ 1 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Cintan ven

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

Koy1840 510(k) Number:_

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).