PROPEP DELIVERY DEVICE

K103200 · Rhythmlink International, LLC · FMF · Apr 12, 2011 · General Hospital

Device Facts

• Record ID: K103200
• Device Name: PROPEP DELIVERY DEVICE
• Applicant: Rhythmlink International, LLC
• Product Code: FMF · General Hospital
• Decision Date: Apr 12, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Indications for Use

A single use disposable introducer needle/cannula intended for precise placement of guide or needle wires, e.g., hook wires or EMG monopolar needles, in non-vascular laparoscopic procedures.

Device Story

Single-use disposable introducer needle/cannula; facilitates precise percutaneous placement of guide/needle wires (e.g., hook wires, EMG monopolar needles) during non-vascular laparoscopic procedures. Device comprises three components: concentric guide tube, introducer needle with ring hub, and introducer needle guide base. Guide base features biocompatible adhesive for patient stabilization; cylindrical tube acts as track for ring hub. Concentric guide tube telescopes out of needle during deployment, maintaining continuous pathway from integrated funnel through base and needle. Used by clinicians in surgical settings to assist in wire placement for procedures including EMG monitoring. Provides temporary percutaneous guide; improves accuracy of wire insertion; benefits patient by facilitating minimally invasive access.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Stainless steel cannula (ISO 9626); biocompatible adhesive (ISO 10993-1). Components: Concentric guide tube, introducer needle with ring hub, guide base. Manual operation; no energy source. Sterile, single-use, disposable.

Indications for Use

Indicated for temporary percutaneous placement of guide or needle wires (e.g., hook wires, EMG monopolar needles) during minimally invasive laparoscopic procedures.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• Light SaberTM Introducer Needle (K013040)

Submission Summary (Full Text)

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# KI03200

## 5. 510(k) Summary

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## APR 1 2 2011

| Company Name: | Rhythmlink International, LLC<br>1140.First Street South<br>Columbia, SC 29209<br>Phone: [phone]<br>FDA Registration #: 1067162<br>Owner Operator #: 9052354 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact Person: | James M. Mewborne<br>Senior Engineer<br>Rhythmlink International, LLC<br>1140 First Street South<br>Columbia, SC 29209<br>Phone: [phone] ext. 101<br>Email: [e-mail] |
| Summary Date: | October 27, 2010 |
| Device Identification: | Proprietary Device Name:<br>Sterile Stainless Steel Introducer Needle/Cannula with Guide Base<br><br>Generic Device Name: Surgical Guide Needle/General and Plastic<br>Surgery, Cannula<br><br>Regulatory Class: Class II<br><br>Classification Name: 21 CFR 878.4800, Manual surgical instrument for<br>general use.<br><br>Product Code: MDM<br><br>This device has not been previously submitted to the FDA. |
| Predicate Device(s): | 510(k) Number: K013040<br>Manufacturer: MINRAD, Inc<br>Trade Name: Light SaberTM Introducer Needle<br>Product Code: MDM |
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| Device Description: | The Stainless Steel Introducer Needle/Cannula with Guide Base is a single<br>use disposable introducer needle/cannula intended for the precise<br>placement of guide or needle wires, e.g., hook wires or EMG monopolar<br>needles, in non-vascular laparoscopic procedures. The Introducer<br>Needle/Cannula provides a temporary percutaneous guide to facilitate the<br>placement of guide or needle wires, e.g., hook wires or EMG monopolar<br>needles, into the abdominal cavity for surgical procedures and specifically<br>for use during EMG monitoring. The Introducer Needle/Cannula with<br>Guide Base has three main components: a Concentric Guide Tube, an<br>Introducer Needle with Ring Hub and an Introducer Needle Guide Base. |
| Concentric Guide Tube: | The Concentric Guide Tube is permanently attached at the top of the<br>Introducer Needle Guide Base and extends into the Introducer Needle. As<br>the Introducer Needle is deployed this tube effectively telescopes out of<br>the Introducer Needle and maintains a continuous concentric pathway<br>from the integrated funnel at the top of the Concentric Guide Tube<br>through the base and through the Introducer Needle. |
| Introducer Needle with Ring Hub: | The Introducer Needle with Ring Hub is made up of two parts: an<br>advancement ring hub and a permanently attached stainless steel cannula<br>needle which meets the recognized consensus standard ISO 9626 First<br>edition. There is an alignment hole in the center of the Ring Hub that<br>mates with the inner diameter of the Introducer Needle. The Guide Tube<br>extends through this alignment hole into the Introducer Needle<br>throughout the insertion and withdrawal procedure. |
| Introducer Needle Guide Base: | The Introducer Needle Guide Base is a molded cylindrical tube with a<br>contoured face perpendicular to the tube. The contoured face has a<br>biocompatible adhesive IAW ISO10993-1 and is used to stabilize the base<br>when the device is placed on the patient. The cylindrical tube acts as a<br>guide along which the Ring Hub slides during Introducer Needle Insertion<br>and withdrawal. |
| Intended Use: | A single use disposable introducer needle/cannula intended for<br>precise placement of guide or needle wires, e.g., hook wires or EMG<br>monopolar needles, in non-vascular laparoscopic procedures. |

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## KIO3200

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This concludes the 510(k) summary.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

Rhythmlink International, LLC % Mr. James M. Mewborne Senior Engineer 1140 First Street South Columbia, South Carolina 29209

APR 1 2 2011

Re: K103200

Trade/Device Name: Sterile Stainless Steel Introducer Needle/Cannula with Guide Base Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF, MDM Dated: March 15, 2011 Received: March 16, 2011

Dear Mr. Mewborne:

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.

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

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Page 2 – Mr. James M. Mewborne

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

Sincerely yours,

A. B. Mte
for

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 4. Indications for Use

510(k) Number (if known): K103200

Device Name: Sterile Stainless Steel Introducer Needle/Cannula with Guide Base

Intended Use:

A single use disposable introducer needle/cannula intended for precise placement of guide or needle wires, e.g., hook wires or EMG monopolar needles, in non-vascular laparoscopic procedures.

Indications for Use:

The Sterile Stainless Steel Introducer Needle/Cannula with Guide Base is indicated for use to provide temporary percutaneous placement of guide or needle wires, e.g., hook wires or EMG monopolar needles, during minimally invasive laparoscopic procedures.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil Rl Ogden for mxn

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103200