(283 days)
Not Found
Not Found
No
The device description and intended use clearly describe a mechanical resheathing device with no mention of software, data processing, or AI/ML terms.
No
The document describes a resheathing device used for safety purposes (single-handed needle resheathing or holding a needle temporarily), not for treating a disease or condition.
No
This device is designed for needle resheathing and holding, which are functions related to safety and temporary storage of needles, not for diagnosing medical conditions or diseases.
No
The device description explicitly states the device is constructed of "plastic and metal" or "plastic and foam," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to facilitate the safe handling and resheathing of needles after use with hypodermic syringes, blood collection devices, or IV administration sets. This is a physical process related to sharps safety, not a diagnostic test performed on biological samples in vitro.
- Device Description: The description focuses on the physical construction and function of the device for needle handling.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
The device is clearly intended for sharps safety and handling, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The plastic and metal resheathers are placed at or near the point of use and allow I he plastic and metal resheathers as o plastic and foam resheather/needle holder is placed at or near the point of use and allows one handed needle resheathing or placed at of theat the polition ass and and are no temporarily hold it prior to disposal.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The Resheathing Devices are constructed of metal or placed securely at or near the point of use and enable the healthcare worker to single handedly recap, or hold a hypodermic syringe, blood. collection device, or IV administration set.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for SAGE PRODUCTS INC. The logo is in black and white, with the word "SAGE" in large, bold letters. Below the word "SAGE" is the word "PRODUCTS INC" in smaller letters. A line is above the word "PRODUCTS INC".
Appendix H
510(k) SUMMARY - Resheathing Devices
| GENERAL: | Establishment Name/ Manufacturing
Site | Sage Products, Incorporated
815 Tek Drive
Crystal Lake, IL 60039-9693 |
|-----------------|-------------------------------------------|-----------------------------------------------------------------------------|
| | Contact Person | Karen Pinto, Regulatory
Affairs Manager |
| | Telephone | (815) 455-4700 ext.1383 |
| | Fax Number | (815) 455-5599 |
| IDENTIFICATION: | Trade Name | Resheathing Devices |
| | Common Name | Resheather/Needle Holder |
| | Classification Name | FMI |
SUBSTANTIAL EQUIVALENCE:
The Sage Products Inc. Resheathing Devices are similar in intended use/substantially equivalent to the following predicate devices:
| MANUFACTURER | PEPCO | On-Gard Systems Inc. |
|---|---|---|
| PRODUCT | NeedleGard II™ | On-Gard Systems® Recapper |
DESCRIPTION:
The Resheathing Devices are constructed of metal or placed securely at or near the point of use and enable the healthcare worker to single handedly recap, or hold a hypodermic syringe, blood. collection device, or IV administration set.
INTENDED USE:
The plastic and metal resheathers are placed at or near the point of use and allow one handed needle resheathing. The plastic and foam resheather/needle holder is placed at or near the point of use and allows one handed needle resheathing or allows the user to place the needle into the foam to temporarily hold it prior to disposal.
TECHNOLOGICAL CHARACTERISTICS:
The Sage Products Inc. Resheathing Devices are similar in their technological characteristics to their predicate devices. The Resheathing Devices are able to accommodate varying sizes of needle sheaths, and can be mounted to surfaces for stabilization.
Response to September 22, 1997 request for additional information
"Innovative health care products since 1971"
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 1998
Ms. Karen Pinto Regulatory Affairs Manager Sage Products, Incorporated 815 Tek Drive Crystal Lake, Illinois 60039-9693
Re : K972705 Sage Resheathers, Needle Resheather/Holder Trade Name: Requlatory Class: II Product Code: FMI April 7, 1998 Dated: Received: April 8, 1998
Dear Ms. Pinto:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਮੈ substantially equivalent determination assumes compliance with --the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
2
Page 2 - Ms. Pinto
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of i
510(k) Number (if known): _ K972705
Device Name: _ Needle Resheather, Needle Resheather/Holder
Indications For Use:
The plastic and metal resheathers are placed at or near the point of use and allow I he plastic and metal resheathers as o plastic and foam resheather/needle holder is placed at or near the point of use and allows one handed needle resheathing or placed at of theat the polition ass and and are no temporarily hold it prior to disposal.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number .
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)