CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT
Device Facts
| Record ID | K110053 |
|---|---|
| Device Name | CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT |
| Applicant | Smiths Medical Asd, Inc. |
| Product Code | CAZ · Anesthesiology |
| Decision Date | Sep 14, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5140 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The CorrectInject™ Safety System is intended for the injection of local or regional anesthetics, narcotics or other medications indicated for neuraxial injection. The system consists of components that have a unique non-Luer taper that allows connection of compatible CorrectInject™ components that, when used together as a system, help reduce the risk of mis-connection that may result in the injection of medications not intended for neuraxial use.
Device Story
CorrectInject™ Safety System is a set of anesthesia conduction components (catheter connector, syringe, filter, filter needle, caps) designed to prevent misconnection with standard Luer taper devices. System uses a proprietary non-Luer taper geometry, incompatible with ISO 594-1/2 Luer standards, to ensure only compatible components connect. Components are color-coded yellow for neuraxial identification. Clinicians assemble components using a twisting motion similar to standard Luer systems. By preventing connection to non-neuraxial Luer devices, the system reduces risk of medication misadministration. Used in clinical settings for epidural/neuraxial anesthesia delivery.
Clinical Evidence
Clinical study involved clinician feedback on the system. 85% of participating clinicians found the system clinically acceptable. Evidence supports that the system is safe, effective, and reduces the risk of misconnections leading to incorrect medication administration.
Technological Characteristics
Components feature a proprietary non-Luer taper geometry. Materials evaluated for biocompatibility per ISO 10993 and chemical characterization per ISO 18. Testing performed against BS 6196, BS EN 1707, ISO 594-1/2, and ISO 7886-1 standards. System is color-coded yellow for neuraxial identification. No electronic or software components; purely mechanical assembly.
Indications for Use
Indicated for patients requiring neuraxial or epidural administration of local anesthetics, narcotics, or other medications. Used by clinicians for injection of medications into the epidural space.
Regulatory Classification
Identification
An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.
Predicate Devices
- Portex® Regional Anesthesia Kits (K965017)
- EpiFuseTM Catheter Connector (K092657)
- Portex Epidural Filter, Model 100/386/010 (K083451)
- BD Luer-Lok Tip Syringe (K980987)
- BD Nokor™ Filter Needle (K801343)
Submission Summary (Full Text)
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# smiths medica
1 4 2012
bringing technology to life
Smiths Medical North America 10 Bowman Drive Keene, NH 03431 T: 603 352 3812 F: 603 357 1614 www.smiths-medical.con
# SECTION 5, 510(k) Summary
#### Company Information:
K110053.
Smiths Medical ASD, Inc. 10 Bowman Dr Keene, NH 03431 (603) 352-3812. prompt 4. ext x2493 Contact: Cynthia Engelhardt Regulatory Affairs Specialist. Summary Prepared: August 20, 2012
#### Product Name:
Trade Name: CorrectInject™ Safety System Common Name: Anesthesia Conduction Kit Classification Name: Anesthesia Conduction Kit, (21 CFR 868.5140, Product Code CAZ)
#### Predicate Device(s):
K965017, Smiths Medical ASD, Inc. Portex® Regional Anesthesia Kits
K092657; EpiFuseTM Catheter Connector
K083451, Portex Epidural Filter, Model 100/386/010, Various Standard and Custom Trays K980987, BD Luer-Lok Tip Syringe
K801343, BD Nokor™ Filter Needle
#### Device Description
The CorrectInject™ System specially designed non-Luer taper aids in preventing a standard Luer taper device from connecting or delivering a medication by the wrong route of administration.
The objective of the Correctingect™ Taper system is to provide a non-Luer style, safety connection system that will help reduce the risk of misconnection.
The Correctinject™ Taper system is intended to connect and be used solely with the components of the Correctiniect™ Safety System. The CorrectIngect™ Safety System is intended to deliver medication to epidural and neuraxial locations.
Correcting Safety System components are considered not to be effectively connected if any of the following apply:
- Attachment to Luer components that requires the use of excessive force, torque, time or 0 manipulation
- Physical resistance to attachment to Luer components beyond that defined in ISO 594-. 1, ISO 594-2 and BS EN 1707
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- If an attachment is made to a standard Luer component, this attachment is non-. functional as indicated by leakage per ISO 594-2, section 4.2 and BS EN 1707 section 4.2
The term "effectively connected" is defined as the ability to assemble linearly with normal clinical assembly force, or securely assemble together CorrectInject™ Safety System components using equivalent force, torque and technique, and resulting in a physically secure and functional assembly as defined by ISO 594 or BS EN 1707. The term "attachment" means to assemble such components that results in an assembly that may, or may not, be physically secure but is not functional as defined by ISO 594-1, ISO 594-2 and BS EN 1707.
The CorrectInject™ Safety System is designed to function in a similar manner as currently available Luer epidural systems. The locking components are attached together with a twisting motion the same as current Luer lock connectors. The difference in this system is that the interconnection taper is not a standard Luer taper (per ISO 594 Parts 1 &2). This CorrectInject™ Safety System is color-coded yellow for a neuraxial system.
The design consists of several unique pieces:
#### 1) Epidural Catheter Connector
The connector is identical to the Luer version of the EpiFuse® connector with the only differences being the taper is a non-Luer CorrectInject™ Taper, the cap is yellow not white and the word CorrectInject® is molded in the connector and printed in blue.
### 2) CorrectInject™ Syringe
The CorrectInject™ Safety System syringe is the same as a standard Luer syringe with the difference being a non-Luer CorrectInject™ Taper molded in place of a standard Luer taper. The CorrectInject™ Safety System syringe is available in 3ml, 5ml, 10ml and 20ml sizes.
#### 3) Filter
The filter is identical to the Luer version of the filter with the only difference being the taper is a non-Luer CorrectInject™ Taper and the rotating collar is yellow and has a non-Luer CorrectInject™ fitting.
#### 4) Filter Needle Assembly
The filter needle is the same as the standard Luer filter needle currently offered by Smiths Medical with an adaptor permanently attached to the Luer providing a non-Luer CorrectInject™ Safety System taper to allow connection to the CorrectInject™ Safety System syringe.
#### 5) Caps
A yellow cap designed to fit the non-standard female side of the catheter connector or filter.
A white transport cap designed to fit the non-standard male side of a CorrectInject™ Safety System syringe.
### 6) CorrectInject™ non-Luer epidural label to identify the catheter and system as a non-Luer system.
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#### Indications for Use:
#### CorrectInject™ Safety System
The CorrectInject™ Safety System is intended for the injection of local or regional anesthetics, narcotics or other medications indicated for neuraxial injection. The system consists of components that have a unique non-Luer taper that allows connection of compatible CorrectInject™ components that, when used together as a system, help reduce the risk of mis-connection that may result in the injection of medications not intended for neuraxial use.
## CorrectInject™ Catheter Connector
The CorrectInject™ Catheter Connector is intended for use with an epidural anesthesia catheter and CorrectInject™ compatible components for the injection of local or regional anesthetics, narcotics or other medications indicated for injection into the epidural space.
#### CorrectIniect™ Syringe
The CorrectInject™ Syringe is intended for use with CorrectInject™ compatible components for the injection of medications.
### CorrectInject™ Filter
The CorrectInject™ anesthesia conduction filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid when used with CorrectInject™ compatible components.
### CorrectInject™ Filter Needle
The CorrectInject™ filter needle is intended to draw up medication when using the CorrectInject™ Syringe.
## CorrectInject™ White Transport Cap
The CorrectInject™ white transport cap is intended to fit the CorrectInject™ syringe.
### CorrectInject™ Yellow Cap
The CorrectInject™ yellow cap is intended to fit the female side of the CorrectInject™ catheter connector or CorrectInject™ filter.
#### Technological Characteristics:
The proposed and predicate devices employ similar technology, i.e. the proposed and the predicate devices are for the injection of local or regional anesthetics, narcotics or other medications indicated for neuraxial injection. The difference is that the proposed system is not a Luer taper, but a non-Luer that is intentionally designed to be incompatible with Luer tapers.
All statements and representations set forth herein regarding or related to "substantially equivalent" or "substantial equivalence" are in the limited context of the definition and purpose of substantial equivalence in the Federal Food, Drug, and Cosmetic Act, as amended, and applicable regulations of the Food and Drug Administration, and are not made in the
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context of, for any purpose related to, or as an admission against interest under, any other laws or regulations, including patent laws (whether in the context of patent infringement or otherwise).
#### Non-Clinical Data:
Non-clinical testing for the CorrectInject™ Safety System has been conducted including visual, performance, dimensional characteristics, biocompatibility, chemical characterization and drug-device stability and compatibility testing.
The CorrectInject™ Safety System meets the requirements of the stated sections of BS 6196:1989, Sterile Epidural Catheters and Introducer Needles for Single Use, Section D.3.3 Only (Strength of union between catheter and catheter connector); BS EN 1707:1997, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings; ISO 594-1, Conical fittings with a 6% (Luer) taper for syringes needles and certain other medical equipment - Part 1 General Requirements; ISO 594-2., Conical fittings with a 6% (Luer) taper for syringes needles and certain other medical equipment -- Part 2 Lock Fittings and ISO 7886-1:1993(E), Sterile hypodermic syringes for single use - Part 1: Syringes for manual use with a modification for the taper.
Chemical characterization has been performed in accordance with ISO Biological evaluation of medical devices - Part 18: Chemical characterization of materials.
Drug-device stability and compatibility testing has been performed to evaluate the stability and compatibility between the components of the CorrectInject™ Safety System and 3 drugs that are representative of the anesthetics, analgesics and narcotics that will be used in a continuous anesthesia system for intermittent administration of local anesthesia. The drug stability and compatibility was determined based on the assays of the drug products before and after infusion. The differences between the average assay result of a sample run in triplicate, and the assay result from its corresponding control sample were within ± 5.0% thus meeting the pre-set acceptance criteria.
#### Clinical Data:
The clinical studies performed by Smiths Medical show that the system is safe and effective and will help reduce the risk of misconnections that lead to mis-injections of medication not intended for the epidural space. Most of the clinicians (85%) that participated in the study felt that the system is clinically acceptable.
#### Conclusion:
The comparison to the predicate devices demonstrates that the proposed device is safe and effective and is substantially equivalent to the predicate device.
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Very truly yours,
Smiths Medical ASD, INC.
8miths Medical, ASD, INC. Cynthia Engelhardt Regulatory Affairs Specialist
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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three horizontal lines and a wavy line at the bottom.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
SEP 14 2012
Smiths Medical ASD. Incorporated Ms. Cynthia Engelhardt Regulatory Affairs Specialist 10 Bowman Drive Keene, New Hampshire 03431
Re: K110053
Trade/Device Name: CorrectInject™ Safety System, Catheter Connector, Filter, Infusio Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: September 7, 2012 Received: September 10, 2012
Dear Ms. Engelhardt:
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- Ms. Engelhardt
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,
Nh for
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
#### Enclosure
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# SECTION 4, Indications for Use Statement
# Indications for Use
#### KU005-2 510(k) Number (if known):
Device Name: CorrectInject™ Safety System
Indications for Use:
The CorrectInject™ Safety System is intended for the injection of local or regional anesthetics, narcotics or other medications indicated for neuraxial injection. The system consists of components that have a unique non-Luer taper that allows connection of compatible Correctinject™ components that, when used together as a system, help reduce the risk of mis-connection that may result in the injection of medications not intended for neuraxial use.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 3 .
L Schulte
Division Sian-Off) Ision of Anesthesiology, General Hospital Infection Control. Dental i
510(k) Number:
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# SECTION 4, Indications for Use Statement
# Indications for Use
#### KIBO53 510(k) Number (if known):
Device Name: CorrectInject™ Catheter Connector
Indications for Use:
The CorrectIniect™ Catheter Connector is intended for use with an epidural anesthesia catheter and Correcting compatible components for the injection of local or regional anesthetics, narcotics or other medications indicated for injection into the epidural space.
#### Device Name: CorrectInject™ Syringe
Indications for Use:
The CorrectInject™ Syringe is intended for use with CorrectInject™ compatible components for the injection of medications.
#### Device Name: CorrectInject™ Filter
Indications for Use:
The CorrectInject™ anesthesia conduction filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid when used with CorrectInject™ compatible components.
Over-The-Counter Use Prescription Use ਮੈ - . AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
Page*2*of*3*
30
510(k) Number:
te 11005
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## SECTION 4, Indications for Use Statement
# Indications for Use
510(k) Number (if known): K ( | 0 0 5 3
Device Name: CorrectInjectTM Filter Needle
Indications for Use:
The CorrectIngect™ filter needle is intended to draw up medication when using the CorrectInject™ Syringe.
Device Name: CorrectInject™ White Transport Cap
Indications for Use:
The CorrectInject™ white transport cap is intended to fit the CorrectInject™ syringe.
Device Name: CorrectInject™ Yellow Cap
Indications for Use:
The CorrectInject™ yellow cap is intended to fit the female side of the CorrectInject™ catheter connector or CorrectInject™ filter.
Over-The-Counter Prescription Use X Use - AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 3 of 3
L. Schultheis
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
31
