(518 days)
No
The summary describes a physical medical device (epidural catheter) and its material properties and performance characteristics. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes
The device is described as an epidural catheter used for the administration of epidural anesthetic, which is a medical intervention intended to treat or alleviate a medical condition (pain) or provide a therapeutic effect (anesthesia).
No
This device, an epidural catheter, is explicitly described for administering anesthetic, not for diagnosing a condition or disease.
No
The device description clearly outlines physical components like a catheter, wire, and sterile kit configurations, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "permit access to the epidural space for the administration of epidural anesthetic." This is a direct intervention on the patient's body for therapeutic purposes (administering medication).
- Device Description: The description details a physical catheter designed to be inserted into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health. This device does not perform any such analysis.
The information provided clearly describes a medical device used for a procedure performed in vivo (within the living body), not in vitro (in glass, or outside the body).
N/A
Intended Use / Indications for Use
The Arrow Epidural Catheter permits access to the epidural space for the administration of epidural anesthetic. The epidural catheter is intended for use up to 72 hours.
Product codes
CAZ, BSO
Device Description
The FlexTip Plus Epidural Catheter has the following characteristics:
- 19 Ga. single lumen 900 mm ●
- Available in open or closed tip .
- Internal radiopaque, echogenic coiled reinforced wire .
- Catheters are provided in sterile kit configurations .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidural space
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Nonclinical Testing
The results of the performance testing. i.e. tensile strength, column strength and flow rate. demonstrate that the FlexTip Plus Closed Tip Epidural Catheter is as safe, as effective and performs comparably to the predicate Epidural catheter.
Pre-clinical evaluations have been conducted on the catheter and extracts thereof. No adverse effects were observed in any in vivo study conducted. In accord with ISO 10993-18 recommendations, Extractable and Leachable (E&L) studies were performed using, Bupivacaine, Naropin, Polocaine, Hydromorphone, Morphine, Meperidine, and Fentanyl. The toxicity of the relevant leachable chemicals relating to these drugs was reviewed and addressed. In addition, a comparative chemical analysis study was conducted to assess potential differences in the E&L profile between devices that were EO sterilized after one cycle versus devices that were processed with two EO cycles. There were no appreciable qualitative differences in the extractable profiles for the one time vs. two time EO-sterilized devices.
The relevant patient contacting components meet the requirements of applicable ISO 10993 Guidelines. The available and relevant toxicological data for a surrogate leachable chemical was reviewed. There was no evidence of significant risk of acute toxicity under the proposed conditions and duration of clinical use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAY 1 6 2012
: … Arrow FlexTip Plus Closed Tip Epidural Catheter
510(k) SUMMARY
Submitter Information
| Name: | Arrow International, Inc. (subsidiary of Teleflex Inc.) |
|---|---|
| Address: | 2400 Bernville Road |
| Reading, PA 19605-9607 | |
| Telephone Number: | (610) 378-0131 |
| Contact Person: | Paul Amudala |
| Regulatory Affairs Specialist | |
| Telephone Number: | (610) 378-0131 Extension 603591 |
| Fax Number: | (610) 374-5360 |
| Email: | paul.amudala@teleflex.com |
| Date Prepared: | Dec 14, 2010 |
| Device Name | |
| Device Trade Name: FlexTip Plus Epidural Catheter | |
| Common Name: | Epidural Catheter |
| Classification Name: Anesthesia Conduction Catheter, CAZ, 21 CFR 868.5140; Anesthesia |
Conduction Catheter, BSO, 868.5120
Predicate Device
The predicate device is Arrow's Continuous Epidural Anesthesia kit with polyurethane catheter, K884552
Device Description
The FlexTip Plus Epidural Catheter has the following characteristics:
- 19 Ga. single lumen 900 mm ●
- Available in open or closed tip .
- Internal radiopaque, echogenic coiled reinforced wire .
- Catheters are provided in sterile kit configurations .
Indications for Use and Intended Use
The Arrow Epidural Catheter permits access to the epidural space for the administration epidural anesthetic. The epidural catheter is intended for use up to 72 hours.
1
Technological Characteristics and Substantial Equivalence
The Arrow FlexTip Plus Epidural Catheter is substantially equivalent to the Continuous Epidural Anesthesia kit with polyurethane catheter (K884552) in terms of overall design, manufacturing process, functional performance, and materials of construction. The indications for use and intended use for the subject device are the same as those for the Continuous Epidural Anesthesia kit with polyurethane catheter.
Nonclinical Testing
The results of the performance testing. i.e. tensile strength, column strength and flow rate. demonstrate that the FlexTip Plus Closed Tip Epidural Catheter is as safe, as effective and performs comparably to the predicate Epidural catheter.
Pre-clinical evaluations have been conducted on the catheter and extracts thereof. No adverse effects were observed in any in vivo study conducted. In accord with ISO 10993-18 recommendations, Extractable and Leachable (E&L) studies were performed using, Bupivacaine, Naropin, Polocaine, Hydromorphone, Morphine, Meperidine, and Fentanyl. The toxicity of the relevant leachable chemicals relating to these drugs was reviewed and addressed. In addition, a comparative chemical analysis study was conducted to assess potential differences in the E&L profile between devices that were EO sterilized after one cycle versus devices that were processed with two EO cycles. There were no appreciable qualitative differences in the extractable profiles for the one time vs. two time EO-sterilized devices.
The relevant patient contacting components meet the requirements of applicable ISO 10993 Guidelines. The available and relevant toxicological data for a surrogate leachable chemical was reviewed. There was no evidence of significant risk of acute toxicity under the proposed conditions and duration of clinical use.
Conclusions
The predicate and the proposed Epidural catheters have the same indications for use and intended use. The results of the testing performed have demonstrated that the Flex Tip Plus Epidural Catheter does not raise new issues of safety or performance and therefore is considered substantially equivalent to the cited predicate device.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 6 2012
Mr. Paul Amudala Regulatory Affairs Specialist Teleflex Incorporated 2400 Bernville Road Reading, Pennsylvania 19605
Re: K103658
Trade/Device Name: FlexTip Plus Closed Tip Epidural Catheter Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: May 2, 2012 Received: May 3. 2012
Dear Mr. Amudala:
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.
3
Page 2 - Mr. Amudala
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,
M 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
4
Indications for Use
K103658 510(k) Number (if known):
Device Name: FlexTip Plus Closed Tip Epidural Catheter
Indications for Use:
The Arrow Epidural Catheter permits access to the epidural space for the administration of epidural anesthetic. The epidural catheter is intended for use up to 72 hours.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schube
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K103658
Arrow International Special 510(k): Page 22 of 75
Page 13 of 41