(41 days)
Continuous nerve block kit and set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
The Arrow Continuous Peripheral Nerve Block Catheter set and kit is comprised of components and accessories which have already been cleared for the same indications for use under earlier 510(k)s. This submission is intended to clarify that the catheter and the associated components and accessories, which we refer to as kits and sets, may be used for non-stimulating procedures. Many of the components and accessories of these kits and sets are already cleared for use in PNB stimulating procedures as well. It is the option of the clinician as to whether they would or would not use stimulation. A typical basic Peripheral Nerve Block ("PNB") set / kit includes the following components. The primary components of any PNB set or kit are: Catheter with stylet, Anesthesia Conduction ("AC") Needle, SnapLock™.
The provided 510(k) summary for the "Continuous Peripheral Nerve Block Catheter Kit and Set" (K121403) states that this medical device submission is intended to clarify that the device, which includes components already cleared for stimulating procedures, may also be used for non-stimulating procedures. The submission explicitly states that no additional bench testing is required because the clarification for non-stimulating use does not change the cleared indications for use and does not introduce any new safety or efficacy concerns compared to the predicate devices. Therefore, the device does not rely on a new study to prove it meets acceptance criteria, but rather on demonstrating substantial equivalence to existing predicate devices.
Based on the provided document, here's the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) submission does not present specific acceptance criteria or performance data for the proposed device from a standalone study because it is claiming substantial equivalence based on the device's components being identical to already cleared predicate devices. The "performance" assessment is comparative to the predicate.
| Acceptance Criteria (based on predicate device characteristics) | Reported Device Performance (Proposed Device) |
|---|---|
| Indications for Use: Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours. | Identical: Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours. |
| Technology: Components of predicate devices (K030937, K021567, K001587) | Identical: Components are identical to the predicates. Including catheter with stylet, Anesthesia Conduction (AC) Needle, SnapLock™. |
| Materials: Materials used in predicate devices (K001587, K021567, K030937) | Identical: All materials in all components are identical to the predicates. |
| Environment of Use: Hospital, sub-acute facilities, pain clinics, physician offices. | Identical: Hospital, sub-acute facilities, pain clinics, physician offices. |
| Patient Population: Patients requiring peripheral nerve block procedures including upper extremity, lower extremity, abdominal and paravertebral locations. | Identical: Patients requiring peripheral nerve block procedures including upper extremity, lower extremity, abdominal and paravertebral locations. |
| Contraindications: Pre-existing nerve injury, neuritis or plexitis; skin/systemic sepsis; bleeding tendencies/anticoagulants. | Identical: Pre-existing nerve injury, neuritis or plexitis; skin/systemic sepsis; bleeding tendencies/anticoagulants. |
| Catheter Specifications (K030937): Effective length (30-90 cm), Gauge (19 Ga, 20 Ga), Material (SS spring core in polyurethane), Echogenic, Color (White/19Ga, Blue/20Ga), Length markings, Exposed length at tip (5mm/19Ga, 6mm/20Ga). | Identical: Meets all specified catheter specifications of the predicate (K030937). |
| AC Needle Specifications (K030937): Length (38-152mm), Gauge (17 Ga, 18 Ga), Geometry (5mm/17Ga, 6mm/18Ga), Exposed Length at Distal needle (5mm/17Ga, 6mm/18Ga). | Identical: Meets all specified AC needle specifications of the predicate (K030937). |
| SnapLock™ Connector (K001587 for non-stimulating, K030937/K021567 for stimulating): Designed for non-stimulating and stimulating procedures. | Identical: Connector for non-stimulating procedures (K001587). Integral wire (K030937), Connection Tab (K021567) for stimulation. |
2. Sample size used for the test set and the data provenance
Not applicable. No new test set or data was generated for this 510(k) submission. The submission relies on demonstrating substantial equivalence to already cleared devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new test set requiring expert ground truth establishment was conducted. The device's safety and effectiveness relies on its similarity to previously cleared devices.
4. Adjudication method for the test set
Not applicable. No new test set requiring an adjudication method was conducted.
5. 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
Not applicable. This device is a physical medical device (catheter kit), not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" in this context is the established safety and effectiveness of the predicate devices based on their prior 510(k) clearances. The current submission argues that the proposed device is identical in design, materials, and intended use (with clarification for non-stimulating procedures) to these predicates.
8. The sample size for the training set
Not applicable. This device is a physical medical device, not an AI/algorithmic device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is a physical medical device and does not involve a training set as would be used for an AI/algorithmic device.
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Continuous Peripheral Nerve Block Catheter Kit and Set
Premarket Notification 510(k) Section 5 - 510(k) Summary
JUN 2 0 2012
Arrow International Inc. 2400 Bernville Road Reading, PA 19605
| Official Contact: | Paul AmudalaRegulatory Affairs Specialist |
|---|---|
| Tel: 610-378-0131 | |
| Fax: 610-478-3179 | |
| Proprietary or Trade Name: | Continuous Peripheral Nerve Block Catheter Kit and Set |
| Common/Usual Name: | Peripheral Nerve Block |
| Classification Name: | Product code - CAZCFR 868-5140 - anesthetic conduction kitClass 2 |
| Predicate Devices: | Arrow - StimuCath™ - K030937 |
Device Description:
The Arrow Continuous Peripheral Nerve Block Catheter set and kit is comprised of components and accessories which have already been cleared for the same indications for use under earlier 510(k)s.
This submission is intended to clarify that the catheter and the associated components and accessories, which we refer to as kits and sets, may be used for non-stimulating procedures. Many of the components and accessories of these kits and sets are already cleared for use in PNB stimulating procedures as well. It is the option of the clinician as to whether they would or would not use stimulation
A typical basic Peripheral Nerve Block ("PNB") set / kit includes the following components. The primary components of any PNB set or kit are:
- Catheter with stylet .
- Anesthesia Conduction ("AC") Needle ●
- SnapLock™ . ・
Indications for Use:
Continuous nerve block kit and set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
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510(k) Summary Page 2 of 6 07-May-2012
Patient Population:
Patients requiring peripheral nerve block procedures including upper extremity, lower extremity, abdominal and paravertebral locations.
Environment of Use:
The environment of use is - hospital, sub-acute facilities, pain clinics, physician offices
Contraindications:
Pre-existing nerve injury, neuritis or plexitis are contraindications for use of continuous nerve or plexus blocks. These conditions should be considered prior to needle or catheter insertion. Skin sepsis in the area where the catheter placement is planned and systemic sepsis are relative contraindications. Extreme care should be taken in patients with bleeding tendencies or patients receiving anticoagulants.
Discussion of Substantial Equivalence
The use of the Continuous Peripheral Nerve Block catheter kit and set for non-stimulating procedures is viewed as substantially equivalent to the predicate device because:
Indications -
The proposed indications for use permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours are identical to predicate - K030937 - StimuCath™.
The use of the proposed PNB catheter for non-stimulating procedures is not new and the use of ultrasound to assist the clinician in catheter tip location and guidance is a common practice. The clinician may use the predicate device StimuCath™ as a non-stimulating catheter simply by not connecting it to a stimulator.
The clarification for non-stimulating use by the clinician does not change the cleared indications for use and does not introduce any new safety or efficacy concerns as compared to the predicates.
Technology -
The components of the proposed device are identical to the predicates.
Materials -
The materials are identical to the predicates.
K030937 - Arrow - StimuCathTM K021567 - Arrow - StimuCath™ K001587 - Arrow - Plastic Reinforced Epidural Catheter
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510(k) Summary Page 3 of 6 07-May-2012
Environment of Use -
The proposed environments of use are identical to the predicate K030937. They are - hospital, sub-acute facilities, pain clinics, and physician offices.
Patient Population -
It is for patients requiring peripheral nerve block procedures including upper extremity, lower extremity, abdominal and paravertebral locations
The patient population is identical to the predicate, K030937 - Arrow StimuCath™.
Comparative Performance
The components are identical to the predicates and the proposed clarification of use for nonstimulating procedures does not change the safety or effectiveness of the device, thus no additional bench testing is required.
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Premarket Notification 510(I
510(k) Summary
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
|---|---|
| 1 | |
| Substantial Equivalence Comparative Table | ||
|---|---|---|
| Features | ProposedPNB Catheter Kit / Set | PredicatesK030937 – StimuCath™ Continuous Nerve Block Set |
| Classification name | Anesthetic Conduction Kit | Anesthetic Conduction Kit |
| Product Code | CAZ868.5140 | CAZ868.5140 |
| Indications for use | Permits placement of catheters next to nerves and nerveplexuses for continuous nerve block anesthesia or analgesiatechniques for periods not exceeding 72 hours | Permits placement of catheters next to nerves and nerveplexuses for continuous nerve block anesthesia oranalgesia techniques for periods not exceeding 72 hours(K030937) |
| Environment of Use | Hospital, sub-acute facilities, pain clinics, physician offices | Hospital, sub-acute facilities, pain clinics, physician offices(K030937) |
| Patient Population | Patients requiring peripheral nerve block proceduresincluding upper extremity, lower extremity, abdominal andparavertebral locations. | Patients requiring peripheral nerve block proceduresincluding upper extremity, lower extremity, abdominal andparavertebral locations.(K030937) The submission was silent on patientpopulation but the intended patient population are identical |
| Contraindications | Pre-existing nerve injury, neuritis or plexitis arecontraindications for use of continuous nerve or plexusblocks. These conditions should be considered prior to | Pre-existing nerve injury, neuritis or plexitis arecontraindications for use of continuous nerve or plexusblocks. These conditions should be considered prior toneedle or catheter insertion. Skin sepsis in the area where thecatheter placement is planned and systemic sepsis arerelative contraindications. Extreme care should be taken inpatients with bleeding tendencies or patients receivinganticoagulants. |
| needle or catheter insertion. Skin sepsis in the area wherecatheter placement is planned and systemic sepsis arerelative contraindications. Extreme care should be taken inpatients with bleeding tendencies or patients receivinganticoagulants. | ||
| Page 3 of 807-May-2012 | ||
| Features | Predicates | |
| Basic components | ProposedPNB Catheter Kit / Set | K030937 – StimuCath™ Continuous Nerve Block SetCatheter with styletAnesthesia Conduction ("AC") NeedleSnap Lock |
| Catheter with styletAnesthesia Conduction ("AC") NeedleSnap Lock | Tunneler(K030937) | |
| Kit / Set Components | Numerous accessories or components may be included in a kit or set.In all cases these have been cleared under previous 510(k) sA partial list of typical kit or set components are:Touhy Needle StatLock DrapeSteriStrips Skin Prep Pad Skin Prep SwabTegaderm Injection needles 18 G, 22 Ga, 25 GaSyringe: 3mL, 10 mL, 20 mL SharpsAway IIChloraPrep Extension Tubing MarkerLidocaine with or without epinephrineStopcock Gauze TowelFilters Filter Straw | Numerous accessories or components may be included in a kit or set.In all cases these have been cleared under previous 510(k) sA partial list of typical kit or set components are:Touhy Needle StatLock DrapeSteriStrips Skin Prep Pad Skin Prep SwabTegaderm Injection needles 18 G, 22 Ga, 25 GaSyringe: 3mL, 10 mL, 20 mL SharpsAway IIChloraPrep Extension Tubing MarkerLidocaine with or without epinephrineStopcock Gauze TowelFilters Filter Straw |
| Component Design and Specifications | ||
| CatheterEffective length | 30 cm to 90 cm | 30 cm to 90 cm (K030937) |
| Catheter Gauge | 19 Ga and 20 Ga | 19 Ga and 20 Ga (K030937) |
| Catheter Body material | Stainless steel spring core encased in a polyurethane outer jacketing | Stainless steel spring core encased in a polyurethane outer jacketing |
| Catheter Outer Jacket | Catheter is echogenic with ultrasound-guided techniquesWhite (19 Ga) and Blue (20 Ga) | Catheter is echogenic (K030937)White (19 Ga) and Blue (20 Ga) (K030937) |
| Color | ||
| Printed along the length | Distal end printed with length markings to aid in depth determination | Distal end printed with length markings to aid in depth determination (K030937) |
| Exposed Length at Distal Tip | 5 mm (19 Ga) and 6 mm (20Ga) | 5 mm (19 Ga) and 6 mm (20Ga) (K030937) |
| 07-May-2012 | ||
| Features | ProposedPNB Catheter Kit / Set | PredicatesK030937 – StimuCath™ Continuous Nerve Block Set |
| Stylet | Clip available if stimulating, but not required to be used, at election of clinician | Clip available if stimulating, but not required to be used, at election of clinician (K021567) |
| Anesthetic Conduction Needle | ||
| Needle Length | 38 mm to 152 mm | 38 mm to 152 mm (K030937) |
| Needle Gauge | 17 Ga and 18 Ga | 17 Ga and 18 Ga (K030937) |
| Needle Geometry | 5 mm (17 Ga) and 6 mm (18 Ga) | 5 mm (17 Ga) and 6 mm (18 Ga) (K030937) |
| Exposed Length -Distal needle | 5 mm (17 Ga) and 6 mm (18 Ga) | 5 mm (17 Ga) and 6 mm (18 Ga) (K030937) |
| SnapLock™ | Connector for non-stimulating procedures | Connector for non-stimulating procedures (K001587) |
| Non-stimulationconnector | ||
| Stimulation connector | Integral wireConnection TabUse of these SnapLock connectors do not require connection to a stimulator, this is only if the clinician wants to | Integral wire (K030937)Connection Tab (K021567) |
| Materials | All materials in all components are identical to the predicates | K001587K021567K030937 |
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Premarket Notification 510(k)
Section 5 – 510(k) Summary
510(k) Summary
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Premarket Notification 510(k)
Section 5 – 510(k) Summary
510(k) Summary
Page 6 of 6
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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Mr. Paul Amudala Regulatory Affairs Specialist Teleflex Inc 2400 Bernville Road Reading, Pennsylvania 19605
JUN 2 0 2012
Re: K121403
Trade/Device Name: Continuous Peripheral Nerve Block Catheter Kit and Set Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: May 7, 2012 Received: May 21, 2012
Dear Mr. Amudula:
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. Amudula
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/Resourcesfor You/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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Indications for Use Statement
510(k) Number:
(To be assigned)
Device Name:
Continuous Peripheral Nerve Block Catheter Kit and Set
Indications for Use:
Continuous nerve block kit and set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
Prescription Use XX (Part 21 CFR 801 Subpart D)
or
Over-the-counter use (21 CFR 807 Subpart C)
Page 1 of 1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Shulton
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
12121403 510(k) Number:
§ 868.5140 Anesthesia conduction kit.
(a)
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.(b)
Classification. Class II (performance standards).