(41 days)
No
The summary describes a physical medical device (catheter kit) and its intended use for nerve blocks. There is no mention of any software, algorithms, or data processing that would suggest the presence of AI or ML. The focus is on the physical components and their established use.
Yes
The device is described as a "continuous nerve block kit and set" used for "continuous nerve block anesthesia or analgesia techniques," which are therapeutic medical procedures.
No
The device is intended for the placement of catheters for continuous nerve block anesthesia or analgesia, which is a therapeutic purpose, not a diagnostic one. While it mentions the use of ultrasound for guidance, the device itself does not perform any diagnostic function.
No
The device description explicitly lists physical components like catheters, needles, and a SnapLock™, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "Continuous nerve block kit and set" used for "placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques." This is a procedural device used in vivo (within the body) for therapeutic or anesthetic purposes.
- Lack of Diagnostic Testing: There is no mention of the device being used to analyze samples or provide diagnostic information about a patient's health status.
Therefore, this device falls under the category of a therapeutic or procedural medical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CAZ
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™ . ・
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
Indicated Patient Age Range
Patients requiring peripheral nerve block procedures including upper extremity, lower extremity, abdominal and paravertebral locations.
Intended User / Care Setting
hospital, sub-acute facilities, pain clinics, physician offices
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 Amudala
Regulatory 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 - CAZ
CFR 868-5140 - anesthetic conduction kit
Class 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.
1
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
2
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.
3
Premarket Notification 510(I
510(k) Summary
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
|---|---|
| 1 | |
| Substantial Equivalence Comparative Table | ||
|---|---|---|
| Features | Proposed | |
| PNB Catheter Kit / Set | Predicates | |
| K030937 – StimuCath™ Continuous Nerve Block Set | ||
| Classification name | Anesthetic Conduction Kit | Anesthetic Conduction Kit |
| Product Code | CAZ | |
| 868.5140 | CAZ | |
| 868.5140 | ||
| 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 | Permits placement of catheters next to nerves and nerve | |
| plexuses for continuous nerve block anesthesia or | ||
| analgesia 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 procedures | |
| including upper extremity, lower extremity, abdominal and | ||
| paravertebral locations. | Patients requiring peripheral nerve block procedures | |
| including upper extremity, lower extremity, abdominal and | ||
| paravertebral locations. | ||
| (K030937) The submission was silent on patient | ||
| population but the intended patient population are identical | ||
| 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 | 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. | ||
| needle or catheter insertion. Skin sepsis in the area where | ||
| catheter placement is planned and systemic sepsis are | ||
| relative contraindications. Extreme care should be taken in | ||
| patients with bleeding tendencies or patients receiving | ||
| anticoagulants. | ||
| Page 3 of 8 | ||
| 07-May-2012 | ||
| Features | Predicates | |
| Basic components | Proposed | |
| PNB Catheter Kit / Set | K030937 – StimuCath™ Continuous Nerve Block Set | |
| Catheter with stylet | ||
| Anesthesia Conduction ("AC") Needle | ||
| Snap Lock | ||
| Catheter with stylet | ||
| Anesthesia Conduction ("AC") Needle | ||
| Snap 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) s | ||
| A partial list of typical kit or set components are: | ||
| Touhy Needle StatLock Drape | ||
| SteriStrips Skin Prep Pad Skin Prep Swab | ||
| Tegaderm Injection needles 18 G, 22 Ga, 25 Ga | ||
| Syringe: 3mL, 10 mL, 20 mL SharpsAway II | ||
| ChloraPrep Extension Tubing Marker | ||
| Lidocaine with or without epinephrine | ||
| Stopcock Gauze Towel | ||
| Filters 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) s | ||
| A partial list of typical kit or set components are: | ||
| Touhy Needle StatLock Drape | ||
| SteriStrips Skin Prep Pad Skin Prep Swab | ||
| Tegaderm Injection needles 18 G, 22 Ga, 25 Ga | ||
| Syringe: 3mL, 10 mL, 20 mL SharpsAway II | ||
| ChloraPrep Extension Tubing Marker | ||
| Lidocaine with or without epinephrine | ||
| Stopcock Gauze Towel | ||
| Filters Filter Straw | ||
| Component Design and Specifications | ||
| Catheter | ||
| Effective 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 techniques | |
| White (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 | Proposed | |
| PNB Catheter Kit / Set | Predicates | |
| K030937 – 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-stimulation | ||
| connector | ||
| Stimulation connector | Integral wire | |
| Connection Tab | ||
| Use 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 | K001587 |
| K021567 | ||
| K030937 |
4
Premarket Notification 510(k)
Section 5 – 510(k) Summary
510(k) Summary
5
Premarket Notification 510(k)
Section 5 – 510(k) Summary
510(k) Summary
Page 6 of 6
6
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.
7
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
8
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: