PAINFUSOR CATHETER

K111031 · Plan 1 Health, S.R.L. · BSO · Jul 8, 2011 · Anesthesiology

Device Facts

• Record ID: K111031
• Device Name: PAINFUSOR CATHETER
• Applicant: Plan 1 Health, S.R.L.
• Product Code: BSO · Anesthesiology
• Decision Date: Jul 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5120
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

PAINfusor Catheter is a closed-tip, multi-holed, radiopaque catheter with a fenestrated length featuring a helical micro-hole pattern; designed for homogenous delivery of local anesthetics or narcotics to surgical wound sites. Used in clinical settings (intraoperative or percutaneous) for pain management; operated by healthcare professionals. Kit includes peel-away introducer needle, occlusive wound dressing, and catheter securement adhesive. Device facilitates targeted medication delivery to surgical sites, potentially improving postoperative pain control. Clinicians use graduated markings for positional reference during placement.

Clinical Evidence

Bench testing only. Validation included biocompatibility, sterilization, packaging, and shelf-life testing per ISO 10555-1:1995. Flow performance testing demonstrated <1% flow reduction across various elastomeric pumps. Kink testing confirmed functional diameter ranges. Peel testing verified sterilization did not impact adhesive strength of wound dressings.

Technological Characteristics

Closed-tip, multi-holed, radiopaque catheter; fenestrated length with helical micro-hole pattern. Constructed of Polyamide Pebax. Includes graduated markings. Supplied as kit with introducer needle, dressing, and adhesive. Sterilization and biocompatibility validated per ISO 10555-1 and ISO 10993.

Indications for Use

Indicated for patients requiring continuous or intermittent delivery of local anesthetics or narcotics to or around surgical wound sites for preoperative, perioperative, and postoperative pain management.

Regulatory Classification

Identification

An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.

Predicate Devices

• I-Flow Corporation's On-Q SliverSoaker Catheter (K051401)
• Pajunk's Wound Infiltration Catheter Kit (K080675)

Submission Summary (Full Text)

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# 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.<br>Via Solari 5, 33020 Amaro (UD) Italy<br>[e-mail], www.plh.eu<br>Tel. [phone]<br>Fax [phone] |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL<br>CORRESPONDENT | Sigi Caron<br>MedTech Consultants, Inc.<br>2400 Via Carrillo<br>Palos Verdes Estates, CA 90274<br>[e-mail]<br>Tel: [phone]<br>Fax: [phone] |
| 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,<br>(K051401), and Pajunk's Wound Infiltration Catheter<br>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.

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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 (<1%) when the PAINfusor catheter is used with different size elastomeric infusion pumps. Kink testing verified that the kinking diameter for the catheter is within the specified acceptable range for functional use of the catheter. A comparison between peel testing results for the occlusive wound dressing verified the sterilization process did not affect the adhesive strength. Sterilization and biocompatibility testing requirements listed in ISO 10555-1 were met.

#### BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

The PAINFUSOR Catheter is an anesthesia conducting catheter substantially equivalent in intended use and mechanism of action to I-Flow Corporation's On-Q SliverSoaker Catheter, (K051401) and Pajunk's Wound Infiltration Catheter Kit (K080675). All three devices are intended to provide delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for pain management. All three devices deliver medication through multiple holes in a fenestrated length of a closed tip catheter. The differences in fenestration pattern did not affect flow characteristics, as demonstrated by flow performance testing. Biocompatibility testing per ISO10993 ensures that, although the PAINfusor is constructed of different materials (Polyamide Pebax® vs. Polyamide (Nylon) for the On-Q SliverSoaker and Polyamide with an Internal stainless steel coil for the Pajunk's Wound Infiltration Catheter Kit), the PAINfusor Catheter is as safe as the predicate devices for its intended use. All tests indicate that the PAINfusor Catheter functions in an equivalent manner to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three abstract shapes resembling birds in flight or flowing ribbons.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Plan 1 Health, S.R.L. C/O Ms. Sigi Caron Regulatory and Clinical Consultant Medtech Consultants, Incorporated 2400 Via Carillo Palos Verdes Estates, California 90274

JUL - 8 2011

Re: K111031 Trade/Device Name: PAINfusor Catheter Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO Dated: April 12, 2011 Received: April 14, 2011

Dear Ms. Caron:

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. Caron

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 CDRH1'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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Anthony D. Newton

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

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### 1. INDICATIONS FOR USE STATEMENT

| 510(k) Number (if known): | K111031 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: PAINfusor Catheter

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.

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)

Ohm Cilla 2/1/14
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

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