AUTODETECT SYRINGE

K041590 · Indigo Orb, Inc. · FMF · Jun 23, 2004 · General Hospital

Device Facts

• Record ID: K041590
• Device Name: AUTODETECT SYRINGE
• Applicant: Indigo Orb, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Jun 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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

Device Story

AutoDetect Syringe is a single-use, spring-loaded, low-friction piston syringe; used during epidural anesthetic procedures to verify needle tip placement in the epidural space via the 'loss of resistance' technique. Device utilizes a light spring-loaded plunger mechanism; allows one-handed operation for detecting entry into the epidural space, compared to traditional two-handed manual syringes. Operated by clinicians in a clinical setting. Output is tactile feedback provided to the clinician upon entry into the epidural space, facilitating accurate needle placement and potentially improving procedural efficiency.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility testing per ISO 10993-1 and syringe performance testing per ISO 7086-1, alongside in-vitro and in-vivo simulation testing to verify performance specifications.

Technological Characteristics

Piston syringe; spring-loaded plunger mechanism. Materials: polypropylene, silicone, polycarbonate. Single-use. Manual operation. No software or electronic components.

Indications for Use

Indicated for use with an epidural needle to verify needle tip placement in the epidural space during epidural anesthetic procedures.

Regulatory Classification

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.

Predicate Devices

• Current Syringe (K001731)
• B-D EPILOR LOR Syringe (K925902)

Submission Summary (Full Text)

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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: | [phone] |
| Fax Number: | [phone] |

#### 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 [phone]. 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 [phone] or [phone] 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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# 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)

Page 1 of 1

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:_