(85 days)
Not Found
No
The summary describes a passive catheter device for delivering medication and does not mention any computational or analytical capabilities that would suggest the use of AI/ML.
Yes.
The device is intended to deliver medication for pain management, which directly addresses a medical condition (pain) to improve health outcomes.
No
The device is intended for the delivery of medication for pain management, not for diagnosing a condition or disease.
No
The device description clearly outlines a physical catheter and related accessory devices (introducer needle, dressing, adhesive), indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver medication to surgical wound sites for pain management. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a catheter designed for delivering fluids, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to administer medication directly to a wound site.
N/A
Intended Use / Indications for Use
The PAINfusor Catheter, along with related accessory devices, is intended for use to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for preoperative, perioperative and postoperative pain management. Routes of administration may be intraoperative or percutaneous.
Product codes
73 BSO
Device Description
The PAINfusor Catheter is a closed tip multi-holed catheter with a fenestrated length that incorporates micro-holes in a helical pattern that allow for homogenous flow of analgesia into a surgical wound. The PAINfusor Catheter is radiopaque and has graduated markings along the length of the catheter for positional reference. It is supplied and packaged as a kit with a peel-away introducer needle, occlusive wound dressing and catheter securement adhesive.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical wound sites
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)
Safety and performance of the PAINfusor Catheter have been validated through bench, biocompatibility, sterilization, packaging, and shelf-life testing. Bench testing confirms that the PAINfusor Catheter can be used according to its intended use and in an equivalent manner to the predicate devices. Testing was conducted in accordance with ISO 10555-1:1995 "Sterile, Single Use Intravascular Catheters- Part 1: General Requirements." Flow performance testing confirmed a low rate of flow reduction (
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).
0
SECTION 2.
510(K) SUMMARY OF SAFETY AND EFFECT
JUL - 8 2011
K) SUMMARY OF SAFETY AND EFFECTIVENESS 2.510(
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT | Plan 1 Health, S.r.l.
Via Solari 5, 33020 Amaro (UD) Italy
info@p1h.it, www.plh.eu
Tel. +39 0433.468376
Fax +39 0433.468383 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL
CORRESPONDENT | Sigi Caron
MedTech Consultants, Inc.
2400 Via Carrillo
Palos Verdes Estates, CA 90274
sigi@medtechconsultants.com
Tel: (310) 377-3069
Fax: (310) 265-7618 |
| TRADE NAME | PAINfusor Catheter |
| COMMON NAME | Anesthesia Conduction Catheter |
| CLASSIFICATION NAME | Catheter, conduction, anesthetic |
| DEVICE CLASSIFICATION | 21 CFR §868.5120 |
| PRODUCT CODES | 73 BSO |
| PREDICATE DEVICE | I-Flow Corporation's On-Q SliverSoaker Catheter,
(K051401), and Pajunk's Wound Infiltration Catheter
Kit (K080675). |
SUBSTANTIALLY EQUIVALENT TO:
The PAINfusor Catheter is substantially equivalent to the I-Flow Corporation's On-Q SliverSoaker Catheter, (K051401), and Pajunk's Wound Infiltration Catheter Kit (K080675). Both predicate devices are Class II devices, and are substantially equivalent to the PAINfusor Catheter in intended use and technological features.
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The PAINfusor Catheter is a closed tip multi-holed catheter with a fenestrated length that incorporates micro-holes in a helical pattern that allow for homogenous flow of analgesia into a surgical wound. The PAINfusor Catheter is radiopaque and has graduated markings along the length of the catheter for positional reference.
1
It is supplied and packaged as a kit with a peel-away introducer needle, occlusive wound dressing and catheter securement adhesive.
INDICATIONS FOR USE:
The PAINfusor Catheter, along with related accessory devices, is intended for use to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for preoperative, perioperative and postoperative pain management. Routes of administration may be intraoperative or percutaneous.
TECHNICAL CHARACTERISTICS:
The PAINFusor Catheter delivers local anesthetics or narcotics through a fenestrated section at the distal end of a closed catheter. The materials incorporated in the PAINfusor Catheter are substantially equivalent to those contained in the predicate devices.
PERFORMANCE DATA:
Safety and performance of the PAINfusor Catheter have been validated through bench, biocompatibility, sterilization, packaging, and shelf-life testing. Bench testing confirms that the PAINfusor Catheter can be used according to its intended use and in an equivalent manner to the predicate devices. Testing was conducted in accordance with ISO 10555-1:1995 "Sterile, Single Use Intravascular Catheters- Part 1: General Requirements." Flow performance testing confirmed a low rate of flow reduction (