(96 days)
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 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 PPS PI® Curved Safety Huber needle does not protect against other routes of blood-borne pathogen transmission.
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 (computerized tomography) 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
The provided 510(k) summary (K120261) describes the PPS PI® Pressure Injectable Safety Huber Needle. This document does not contain the level of detail required for a comprehensive description of acceptance criteria and a study proving the device meets those criteria, particularly for an AI/ML powered device. This device is a medical instrument (needle) and not an AI/ML algorithm.
Therefore, many of the requested fields cannot be filled. However, based on the information provided, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format typically seen for AI/ML device studies (e.g., sensitivity, specificity, AUC). Instead, performance is demonstrated through general safety and functionality testing and biocompatibility.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | ✓ Meets biocompatibility requirements |
| Safety and Functionality | ✓ Meets safety and functionality requirements |
| Pressure Injection Rates | - 5 mL/sec. for 19 Ga. needle- 5 mL/sec. for 20 Ga. needle- 2 mL/sec. for 22 Ga. needle. |
| Needle Stick Prevention | Indicated to prevent blood-borne pathogen exposures caused by accidental needle punctures. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. The document generally states "Performance data included with this submission" which typically refers to internal test reports, but the specifics of sample sizes, data provenance (e.g., country of origin, retrospective/prospective nature) for the safety and functionality tests are not disclosed in public-facing summarized documents like the 510(k).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable/provided. For a physical medical device like a Huber needle, ground truth is typically established through engineering specifications, material testing standards, and in vitro or in vivo (if applicable) performance testing against defined physical and mechanical benchmarks, not by expert consensus in image interpretation or diagnosis.
4. Adjudication Method for the Test Set
This information is not applicable/provided for this type of device. Adjudication methods like 2+1 or 3+1 are relevant for studies where human readers are making subjective interpretations, typically in diagnostic imaging with AI.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. MRMC studies are typically used to evaluate the impact of AI on human reader performance, which is not relevant for this physical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
No, a standalone algorithm performance study was not done. This device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for this device would be based on:
- Engineering Specifications: Adherence to design tolerances, material properties, and mechanical strength requirements.
- Biocompatibility Standards: Evidence that the materials used do not elicit adverse biological responses.
- Functional Testing: Verification that the needle delivers fluids at specified rates, the safety mechanism activates correctly, and the luer-lock connectors function as intended.
- Predicate Device Equivalence: Comparison to legally marketed predicate devices in terms of intended use, materials, design, and functionality.
8. The Sample Size for the Training Set
This information is not applicable/provided. This device is not an AI/ML algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided. As above, there is no "training set" for a physical medical device.
Summary regarding the device and AI/ML criteria:
The K120261 submission pertains to a physical medical device, the PPS PI® Pressure Injectable Safety Huber Needle. As such, the concept of "acceptance criteria" and "studies" as typically applied to AI/ML powered devices (e.g., diagnostic accuracy, sensitivity, specificity, MRMC studies) are not directly relevant. The performance data focuses on biocompatibility, safety, functionality, and specific flow rates, which are typical for this class of device. The primary method of demonstrating effectiveness and safety, and therefore meeting acceptable criteria, is through comparison to predicate devices and adherence to general device testing standards.
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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 - FRANCEPhone +33(0)3 44 08 17 00Fax +33(0)3 44 08 17 01Website: www.perousemedical.com | ||
|---|---|---|---|
| Contacts | Marie-Noëlle EROUT - Quality & Regulatory Affairs Director - e-mail :m-n.erout@perousemedical.com | ||
| Preparationdate | December 16th 2011 | ||
| Trade Name | PPS PI® Pressure Injectable Safety Huber Needle | ||
| CommonName | Intravascular administration set | ||
| ClassificationName | set, administration, intravascular | ||
| Legallymarketedpredicatedevices | - Power Loc safety infusion set, Bard access systems (510(k) n° K082306). Theindications for use are the same as the PPS PI® Pressure Injectable Safety HuberNeedle- 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 needlemounted with one connection line ideal for accessing pressure injectable ports. Thisdevice allows pressure injection of contrast media during CT (computerizedtomography) scans or MRI (magnetic Resonance imaging) and is MR Conditional.The PPS PI® curved Huber needle is available in various lengths and diameters; with orwithout a lateral injection site.Luer-Lock connectors, are provided, on which closed protective caps are screwed (endof the main line and of the Y site) which must not be used as sealing caps. One clampis 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 (horizontalplunger). |
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
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PERQUSE
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| STEP 2: Preparation:Tilt the plunger from thehorizontal position to a verticalposition. | |
|---|---|
| STEP 3:Using your thumb, lower theplunger to bring it in contact withthe skin. Lift the extractor (bottomto top motion) until the completelocking of the needle: you shouldhear 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 withan 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 SafetyHuber needle does not protect against other routes of blood-borne pathogentransmission. |
| Performancedata | Performance data included with this submission✓ Biocompatibility✓ Safety and functionality testing |
| Substantialequivalence | PPS PI® Pressure Injectable Safety Huber Needle connecting lines are substantiallyequivalent to:- Bard Power Loc predicate device in term of intended use and technologicalcharacteristics (materials, design and functionality).- POLYPERF Safe predicate device except for the pressure injection of contrastmedia |
| Conclusion | Performance data demonstrate safety, effectiveness and substantial equivalence |
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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.
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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
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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)
§ 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.