(96 days)
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
This device is primarily used for the administration or withdrawal of fluids and pressure injection of contrast media, which are diagnostic and procedural functions rather than direct therapeutic treatments.
No.
The document describes a Huber needle used for fluid administration/withdrawal and pressure injection, not for diagnosing medical conditions. While it mentions use during CT or MRI scans (which are diagnostic procedures), the device itself is an accessory for fluid delivery, not for generating diagnostic information.
No
The device description clearly describes a physical needle and associated hardware components (connection line, Luer-Lock connectors, caps, clamps). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of this device is for administering or withdrawing fluids and injecting contrast media directly into the central venous system of a patient. This is an in-vivo (within the living body) application, not an in-vitro (in glass/outside the body) application.
- The device description focuses on the physical characteristics and function of a needle and connection line. It describes how the device is used to access an implanted port and facilitate the flow of fluids or contrast media. This aligns with a medical device used for direct patient care, not for analyzing biological samples.
Therefore, the PPS PI® curved safety Huber needle is a medical device used for patient treatment and procedures, not an IVD used for diagnostic testing of biological specimens.
N/A
Intended Use / Indications for Use
The PPS PI® curved safety Huber needle is indicated for:
- Administration or withdrawal of fluids through implanted ports.
- Pressure injection of contrast media into the central venous system only with an implantable infusion port that is also indicated for pressure injection.
-The maximum recommended infusion rate at 11,8 cPs is : - 5mL/sec. for 19Ga. needle
- 5 mL/sec. for 20 Ga. needle
- 2 mL/sec. for 22 Ga. needle.
- The PPS PI® Curved Safety Huber needle is indicated to PPS PI® Curved Safety Huber needle does not protect against other routes of blood-borne pathogen transmission.
Product codes (comma separated list FDA assigned to the subject device)
FPA, FMI
Device Description
The PPS PI® Pressure Injectable Safety Huber Needle is a curved safety Huber needle mounted with one connection line ideal for accessing pressure injectable ports. This device allows pressure injection of contrast media during CT (computerized tomography) scans or MRI (magnetic Resonance imaging) and is MR Conditional. The PPS PI® curved Huber needle is available in various lengths and diameters; with or without a lateral injection site. Luer-Lock connectors, are provided, on which closed protective caps are screwed (end of the main line and of the Y site) which must not be used as sealing caps. One clamp is also provided (2 clamps for references with "Y" site) PPS PI® Pressure Injectable Safety Huber Needle is single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system
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
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.
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
§ 880.5440 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
MAY - 2 2012
ROUSE DIC
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS As required by section 807.92(c)
| Submitter | PEROUSE MEDICAL - 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.perousemedical.com | | |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contacts | Marie-Noëlle EROUT - Quality & Regulatory Affairs Director - e-mail :
m-n.erout@perousemedical.com | | |
| Preparation
date | December 16th 2011 | | |
| Trade Name | PPS PI® Pressure Injectable Safety Huber Needle | | |
| Common
Name | Intravascular administration set | | |
| Classification
Name | set, administration, intravascular | | |
| Legally
marketed
predicate
devices | - Power Loc safety infusion set, Bard access systems (510(k) n° K082306). The
indications for use are the same as the PPS PI® Pressure Injectable Safety Huber
Needle
- Polyperf Safe (510(k) n°K063631). The indications for use are the same than PPS PI®
Pressure Injectable Safety Huber Needle without the pressure injection ability. | | |
| Description | The PPS PI® Pressure Injectable Safety Huber Needle is a curved safety Huber needle
mounted with one connection line ideal for accessing pressure injectable ports. This
device allows pressure injection of contrast media during CT (computerized
tomography) scans or MRI (magnetic Resonance imaging) and is MR Conditional.
The PPS PI® curved Huber needle is available in various lengths and diameters; with or
without a lateral injection site.
Luer-Lock connectors, are provided, on which closed protective caps are screwed (end
of the main line and of the Y site) which must not be used as sealing caps. One clamp
is also provided (2 clamps for references with "Y" site)
PPS PI® Pressure Injectable Safety Huber Needle is single use | | |
| | Safety removal of the PPS PI® Pressure Injectable Safety Huber Needle: | | |
| | Image: [Safety removal of the PPS PI Pressure Injectable Safety Huber Needle] | | |
| | STEP 1:
Usual use position (horizontal
plunger). | | |
Slage vodal Route du Mancil
60173 Ivry le Temple France Tel. 33 (0)3 44 08 17 00 Fax 23 (0)3 44 08 17 01
Division Oncologia 6 Cardi ovasculairo Roube du Mandir 60173 Ivry le Temple, France
Tel. 33 (012 44 (08 17 00) Fax. 33 (0)3 44 08 17 01
Division Imagerie Interventionnelle & BtoB 135, Route Neuve 69540 Irigny France Tel . 33 00 1 72 39 74 14 Fax 33 (0)4 78 51 89 67
rur ber SAS au capital de 131 70. SIREN 317 883 999 RCS N TVA traccoun FR 01 3 17 887 999
1
PERQUSE
商建 |
,在
| | STEP 2: Preparation:
Tilt the plunger from the
horizontal position to a vertical
position. |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | STEP 3:
Using your thumb, lower the
plunger to bring it in contact with
the skin. Lift the extractor (bottom
to top motion) until the complete
locking of the needle: you should
hear a "CLICK" sound. |
| Intended Use | The PPS PI® curved safety Huber needle is indicated for:
- Administration or withdrawal of fluids through implanted ports.
- Pressure injection of contrast media into the central venous system only with
an implantable infusion port that is also indicated for pressure injection.
-The maximum recommended infusion rate at 11,8 cPs is : - 5mL/sec. for 19Ga. needle
- 5 mL/sec. for 20 Ga. needle
- 2 mL/sec. for 22 Ga. needle.
- The PPS PI® Curved Safety Huber needle is indicated to PPS PI® Curved Safety
Huber needle does not protect against other routes of blood-borne pathogen
transmission. |
| Performance
data | Performance data included with this submission
✓ Biocompatibility
✓ Safety and functionality testing |
| Substantial
equivalence | PPS PI® Pressure Injectable Safety Huber Needle connecting lines are substantially
equivalent to: - Bard Power Loc predicate device in term of intended use and technological
characteristics (materials, design and functionality). - POLYPERF Safe predicate device except for the pressure injection of contrast
media |
| Conclusion | Performance data demonstrate safety, effectiveness and substantial equivalence |
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Isabelle Jeanty Deputy General Manager & Quality & Regulatory Affairs Director Perouse Medical Route Du Manoir 60173 Ivry Le Temple France
MAY - 2 2012
Re: K120261
Trade/Device Name: PPS PI® Pressure Injectable Safety Huber Needle Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: II Product Code: FPA, FMI Dated: March 12, 2012 · Received: March 13, 2012
Dear Ms. Jeanty:
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.
3
Page 2- Ms. Jeanty
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 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,
Anthony D. Adkin
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
Enclosure
4
510k Premarket Notification PPS PI® Pressure Injectable Safety Huber Needle January 2012
Image /page/4/Picture/1 description: The image shows the words "PEROUSE MEDICAL" in a bold, sans-serif font. The word "PEROUSE" is in a larger font size than the word "MEDICAL", and it is positioned above the word "MEDICAL". The letter "O" in "PEROUSE" is stylized with a circular design in the center. The text is black against a white background.
INDICATIONS FOR USE
12026 510(k) Number (if known): . Device Name: PPS PI Pressure Injectable Safety Huber Needle
Indications for Use:
The PPS PI curved safety Huber needle is indicated for:
-
Administration or withdrawal of fluids through implanted ports.
-
Pressure injection of contrast media into the central venous system only with an implantable infusion port that is also indicated for pressure injection.
-The maximum recommended infusion rate at 11,8 cP is :
he maximum recommended infusion rate at 2
5 ml/min for 10 G controlle
-
5 mL/sec. for 19 Ga. needle
-
5 mL/sec. for 20 Ga. needle
-
2 mL/sec. for 22 Ga. needle.
-
The PPS PI Curved Safety Huber needle is indicated to prevent blood-borne pathogen exposures caused by accidental needle punctures. The PPS PI Curved Safety Huber needle does not protect against other routes of blood-borne pathogen transmission.
Rell C. Ch 5/1/2012
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K120261
| · 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)