(162 days)
Not Found
No
The device description and intended use focus on a mechanical introducer needle/cannula and do not mention any computational or analytical capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is described as an introducer needle/cannula for precise placement of guide or needle wires, not for treating a disease or condition.
No
The device is used to facilitate the placement of wires, such as hook wires or EMG monopolar needles, for surgical procedures and EMG monitoring. It provides a temporary guide. However, it does not directly diagnose a condition or disease; it is a tool for other diagnostic or surgical instruments.
No
The device description clearly outlines physical components made of stainless steel (needle, cannula, guide base), 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:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states the device is an introducer needle/cannula used for the placement of guide or needle wires within the body during laparoscopic procedures. It's a surgical tool used for access and guidance, not for testing biological samples.
- Intended Use: The intended use is for "precise placement of guide or needle wires... in non-vascular laparoscopic procedures." This is a procedural function, not a diagnostic one based on analyzing biological samples.
The device is a surgical instrument used in vivo (within the living body) for a procedural purpose.
N/A
Intended Use / 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.
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.
Product codes
MDM, FMF
Device Description
The Stainless Steel Introducer Needle/Cannula with Guide Base is a single use disposable introducer needle/cannula intended for the precise placement of guide or needle wires, e.g., hook wires or EMG monopolar needles, in non-vascular laparoscopic procedures. The Introducer Needle/Cannula provides a temporary percutaneous guide to facilitate the placement of guide or needle wires, e.g., hook wires or EMG monopolar needles, into the abdominal cavity for surgical procedures and specifically for use during EMG monitoring. The Introducer Needle/Cannula with Guide Base has three main components: a Concentric Guide Tube, an Introducer Needle with Ring Hub and an Introducer Needle Guide Base.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity
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)
Not Found
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
§ 880.5860 Piston syringe.
(a)
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.(b)
Classification. Class II (performance standards).
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KI03200
5. 510(k) Summary
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APR 1 2 2011
| Company Name: | Rhythmlink International, LLC
1140.First Street South
Columbia, SC 29209
Phone: 803-252-1222
FDA Registration #: 1067162
Owner Operator #: 9052354 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact Person: | James M. Mewborne
Senior Engineer
Rhythmlink International, LLC
1140 First Street South
Columbia, SC 29209
Phone: 803-252-1222 ext. 101
Email: jmewborne@rhythmlink.com |
| Summary Date: | October 27, 2010 |
| Device Identification: | Proprietary Device Name:
Sterile Stainless Steel Introducer Needle/Cannula with Guide Base
Generic Device Name: Surgical Guide Needle/General and Plastic
Surgery, Cannula
Regulatory Class: Class II
Classification Name: 21 CFR 878.4800, Manual surgical instrument for
general use.
Product Code: MDM
This device has not been previously submitted to the FDA. |
| Predicate Device(s): | 510(k) Number: K013040
Manufacturer: MINRAD, Inc
Trade Name: Light SaberTM Introducer Needle
Product Code: MDM |
| | |
| Device Description: | The Stainless Steel Introducer Needle/Cannula with Guide Base is a single
use disposable introducer needle/cannula intended for the precise
placement of guide or needle wires, e.g., hook wires or EMG monopolar
needles, in non-vascular laparoscopic procedures. The Introducer
Needle/Cannula provides a temporary percutaneous guide to facilitate the
placement of guide or needle wires, e.g., hook wires or EMG monopolar
needles, into the abdominal cavity for surgical procedures and specifically
for use during EMG monitoring. The Introducer Needle/Cannula with
Guide Base has three main components: a Concentric Guide Tube, an
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
Introducer Needle Guide Base and extends into the Introducer Needle. As
the Introducer Needle is deployed this tube effectively telescopes out of
the Introducer Needle and maintains a continuous concentric pathway
from the integrated funnel at the top of the Concentric Guide Tube
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
advancement ring hub and a permanently attached stainless steel cannula
needle which meets the recognized consensus standard ISO 9626 First
edition. There is an alignment hole in the center of the Ring Hub that
mates with the inner diameter of the Introducer Needle. The Guide Tube
extends through this alignment hole into the Introducer Needle
throughout the insertion and withdrawal procedure. |
| Introducer Needle Guide Base: | The Introducer Needle Guide Base is a molded cylindrical tube with a
contoured face perpendicular to the tube. The contoured face has a
biocompatible adhesive IAW ISO10993-1 and is used to stabilize the base
when the device is placed on the patient. The cylindrical tube acts as a
guide along which the Ring Hub slides during Introducer Needle Insertion
and withdrawal. |
| 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. |
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KIO3200
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This concludes the 510(k) summary.
:
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2
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
3
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 (800) 638-2041 or (301) 796-7100 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
4
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