(303 days)
Not Found
No
The summary describes a mechanical device for fluid administration and withdrawal, with no mention of AI/ML terms or functionalities.
No.
The device is indicated for fluid administration or withdrawal to/from implanted ports, which are functions of a medical device, not a therapeutic device designed to treat a medical condition.
No
The 'Intended Use / Indications for Use' section states that the device is "indicated for the administration into or withdrawal of fluids from implanted ports" and "designed to help protect against exposure to blood caused by accidental needle stick injuries." These functions are therapeutic or preventative, not diagnostic. There is no mention of the device being used to identify or interpret medical conditions.
No
The device description clearly indicates physical components like "Connection lines with Huber needle," "Curved needle with luer lock and clamp," and "Safety Huber needle with connecting line," which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the administration and withdrawal of fluids from implanted ports, and for protection against needle stick injuries. This is a direct interaction with the patient's body for therapeutic or procedural purposes.
- Device Description: The device is described as connecting lines with Huber needles, designed for accessing implanted ports. This is a medical device used for fluid management and safety during procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests in vitro (outside the body) on biological samples. This device is used in vivo (within the body) for direct patient care.
N/A
Intended Use / Indications for Use
POLYPERF® / POLYPERF® Safe connecting lines are indicated for the administration into or withdrawal of fluids from implanted ports. POLYPERF® Safe is designed to help protect against exposure to blood caused by "accidental needle stick injuries."
Product codes
FPA, FMI
Device Description
POLYPERF®: Connection lines with Huber needle. Curved needle with luer lock and clamp with and without injection site.
POLYPERF® Safe: Safety Huber needle with connecting line. Prevention of ABE. Easy to perform positive Pressure.
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)
Performance data included with this submission:
✓ Biocompatibility
✓ Safety and functionality testing
✓ Clinical evaluation of the handiness and the safety of use of Polyperf® safe
Performance data demonstrates safety, effectiveness and substantial equivalence
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
GRIPPER PLUS NEEDLE -DELTEC, INC - K021999, GRIPPER NEEDLE - DELTEC, INC - K896346
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
510k Premarket Notification POLYPERF® / POLYPERF® Safe
Image /page/0/Picture/1 description: The image shows a logo with a stylized letter 'P' at the top, resembling a drop or a stylized leaf. Below the symbol, the word 'PEROUSE' is written in a bold, sans-serif font. Underneath 'PEROUSE', the word 'laboratoires' is written in a smaller, lighter font, suggesting that the logo represents a laboratory or a company named Perouse Laboratories.
Ko6363
510(k) Summary of Safety and EFFECTIVENESS
OCT 5 * 2007
As required by section 807.92(c)
| Submitter | Laboratoire PEROUSE Route du Manoir 60173 IVRY LE TEMPLE FRANCE
Phone +33(0)3 44 08 17 00
Fax +33(0)3 44 08 17 01
Website: www.perouse.com | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Contacts | Marie-Noëlle EROUT – Quality Manager – e-mail marie-
noelle.erout@perouse.com
Regulatory contact: Idée Consulting (FRANCE)
Isabelle DRUBAIX e-mail : idrubaix@nordnet.fr | |
| Preparation date | August 22, 2006 | |
| Trade Name | POLYPERF® / POLYPERF® Safe | |
| Common Name | Intravascular administration set | |
| Classification Name | set, administration, intravascular | |
| Legally marketed
predicate devices | GRIPPER PLUS NEEDLE -DELTEC, INC - K021999
GRIPPER NEEDLE - DELTEC, INC - K896346 | |
| Description | POLYPERF®
Connection lines with Huber
needle. Curved needle with
luer lock and clamp with
and without injection site. | POLYPERF® Safe
Safety Huber needle
with connecting line.
Prevention of ABE.
Easy to perform positive
Pressure. |
| | Image: connection lines with huber needle | Image: safety huber needle |
1
510k Premarket Notification POLYPERF® / POLYPERF® Safe
Image /page/1/Picture/1 description: The image shows the logo for PEROUSE Laboratories. The logo consists of a stylized letter "P" in a circle above the word "PEROUSE" in bold, block letters. Below "PEROUSE" is the word "laboratories" in a smaller, sans-serif font.
| Intended Use | POLYPERF® / POLYPERF® Safe connecting lines are indicated for the
administration into or withdrawal of fluids from implanted ports.
POLYPERF® Safe is designed to help protect against exposure to blood
caused by accidental needle stick injuries. |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance data | Performance data included with this submission
✓ Biocompatibility
✓ Safety and functionality testing
✓ Clinical evaluation of the handiness and the safety of use of
Polyperf® safe |
| Substantial equivalence | POLYPERF® / POLYPERF® Safe connecting lines are substantially
equivalent to their predicate devices in term of intended use and
technological characteristics (materials, design and functionality). |
| Conclusion | Performance data demonstrates safety, effectiveness and substantial
equivalence |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. Above the caduceus, the text "HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion. Below the caduceus, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marie-Noëlle EROUT Quality and Regulatory Affairs Manager Laboratoires PEROUSE Route du Manoir 60173 Ivry Le Temple · FRANCE
OCT 5 " 2007
Re: K063631
Trade/Device Name: POLYPERF and POLYPERF® Safe Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA, FMI Dated: September 10, 2007 Received: September 13, 2007
Dear Ms. EROUT:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Ms. EROUT
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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). please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510k Premarket Notification POLYPERF® / POLYPERF® Safe
Image /page/4/Picture/1 description: The image shows a logo for PEROUSE laboratoires. The logo features a stylized letter 'P' in a dark, textured oval shape above the word "PEROUSE" in a bold, sans-serif font. Below "PEROUSE" is the word "laboratoires" in a smaller, sans-serif font.
INDICATIONS FOR USE
510(k) Number (if known): Device Name: POLYPERF® / POLYPERF® Safe Indications for Use:
POLYPERF® / POLYPERF® Safe connecting lines are indicated for the administration into or withdrawal of fluids from implanted ports. POLYPERF® Safe is designed to help protect against exposure to blood caused by "accidental needle stick injuries."
Prescription Use Over-The-Counter Use > AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Affice of Deythe Evaluation (ODE)
Clem L. Bennett for ADW
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: KD6363/00012