(178 days)
Not Found
No
The summary describes a mechanical needlestick prevention device and performance testing related to physical properties and flow rates, with no mention of AI or ML.
No
The device is a vascular access device for temporary cannulation used in procedures requiring an extracorporeal circuit. Its primary function is to facilitate access and aid in needlestick prevention, not to treat a disease or condition.
No
Explanation: The device is a vascular access device used for temporary cannulation in procedures requiring an extracorporeal circuit. Its stated purpose is for access and fluid transfer, not for diagnosing medical conditions.
No
The device description and performance studies clearly indicate this is a physical medical device (fistula needle set) with a mechanical needlestick prevention feature, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes the Fresenius PUNCTUR-GUARD® Fistula Needle Set as a vascular access device used for temporary cannulation in procedures requiring an extracorporeal circuit (like dialysis). Its primary function is to provide a physical connection to the bloodstream.
- Lack of Diagnostic Function: The device does not perform any tests on bodily fluids or tissues to diagnose or monitor a condition. It is a tool for accessing the vascular system.
The device is a medical device, specifically a vascular access device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Fresenius PUNCTUR-GUARD® Fistula Needle Set is indicated for use as a non-implantable (less than 30 days use) vascular access device for temporary cannulation in procedures requiring an extracorporeal circuit. The set includes a needlestick prevention device using PUNCTUR-GUARD® technology. The features of this device may aid in the prevention of needlestick injury. This device is intended for single use only.
Product codes
78 FIE
Device Description
The Fresenius PUNCTUR-GUARD® Fistula Needle Set is a non-implantable (less than 30 days use) vascular access device that includes a needlestick prevention device using PUNCTUR-GUARD® technology. It is intended for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vascular access
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
The results of design verification indicate that the Fresenius PUNCTUR-GUARD® Fistula Needle Set's performance is equivalent to other fistula needles currently in commercial distribution. The following testing was performed as part of design verification: ISO 10993-1 Biocompatibility (Passed), Sheath Removal Force (All samples passed), Penetration Testing (All samples passed), Tubing Tensile Strength (All samples passed), Tubing/Luer Bond Strength (All samples passed), Tubing/Third Wing Bond Strength (All samples passed), Wing Body/Third Wing Disassembly Force (All samples passed), Front Cannula/Wing Body Bond Strength (All samples passed), Blunting Member/Third Wing Bond Strength (All samples passed), Safety Feature Activation Torque Testing (All samples passed), Lock Force - Spring Arm (All samples passed), Positive Pressure Leak Testing (All samples passed), Negative Pressure Leak Testing (All samples passed), Tip to Tip Distance Testing (All samples passed).
Rate Flow vs. Pressure Drop result: Maximum recommended flow rate for each gauge size: 17G ≤200 ml/min; 16G ≤300 ml/min; 15G ≤400 ml/min; 14G ≤600 ml/min.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5540 Blood access device and accessories.
(a)
Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device.
(2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle).
(3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
(b)
Classification. (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated.
(B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided.
(C) Priming volumes must be established.
(D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(E) Air leakage testing and liquid leakage testing must be conducted.
(F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage.
(G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern.
(H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established.
(iii) Performance data must demonstrate the sterility of the device.
(iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing.
(v) Labeling of implanted blood access devices for hemodialysis must include the following:
(A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated.
(B) Labeling must specify the forward and reverse recirculation rates.
(C) Labeling must provide the arterial and venous priming volumes.
(D) Labeling must specify an expiration date.
(E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.
(F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient.
(G) Labeling must include a patient implant card.
(H) The labeling must contain comprehensive instructions for the following:
(
1 ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;(
2 ) Proper care and maintenance of the device and device exit site;(
3 ) Removal of the device;(
4 ) Anticoagulation;(
5 ) Management of obstruction and thrombus formation; and(
6 ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:
(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.
(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following:
(A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied.
(B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties.
(C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens.
(D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness.
(viii) The following must be included for A-V shunt cannulae (with vessel tips):
(A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply.
(B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(2) Class II (performance standards) for the nonimplanted blood access device.
(3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Fresenius PUNCTUR-GUARD® Fistula Needle Set 510(k) Premarket Notification
Summary of Safety and Effectiveness
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.
MAR 2 0 2003
A. Submitter's Information:
| Name: | Fresenius Medical Care North America |
|---|---|
| Address: | 95 Hayden Ave |
| Two Ledgemont Center | |
| Lexington, MA 02420 | |
| Phone: | 1-781-402-9785 |
| Fax: | (781) 402-9635 |
| Contact Person: | Nichole Riek, Regulatory Affairs Supervisor |
| Date of Preparation: | 20 December 2002 |
B. Device Name:
| Trade Name: | Fresenius PUNCTUR-GUARD® Fistula Needle
Set |
|----------------------|------------------------------------------------|
| Common/Usual Name: | Fistula Needle |
| Classification Name: | Blood Access Device |
C. Predicate Device Name:
The predicate devices for the Fresenius Punctur-Guard Fistula Needle Sets are Bio-Plexus Punctur-Guard Winged Set for Blood Collection (#K003827, 1/8/2001) and the JMS AV Fistula Needle Set "Wing Eater" (#K010406, 6/20/01).
D. Indications for Use:
The Fresenius PUNCTUR-GUARD® Fistula Needle Set is indicated for use as a nonimplantable (less than 30 days use) vascular access device for temporary cannulation in procedures requiring an extracorporeal circuit. The set includes a needlestick prevention device using PUNCTUR-GUARD® technology. The features of this device may aid in the prevention of needlestick injury. This device is intended for single use only.
1
Summary of Safety and Effectiveness
E. Substantial Equivalence:
1. Is the product a device?
YES - The Fresenius Punctur-Guard Fistula Needle Set is a device pursuant to 21 CFR §201 [321] (h).
2. Does the new device have the same intended use?
YES - The intended use for the Fresenius Punctur-Guard Fistula Needle Set is equivalent to that for the JMS AV Fistula Needle Set "Wing Eater" (#K010406, 6/20/01).
· Fresenius Punctur-Guard Fistula Needle Set
The Fresenius PUNCTUR-GUARD® Fistula Needle Set is indicated for use as a non-implantable (less than 30 days use) vascular access device for temporary cannulation in procedures requiring an extracorporeal circuit. The set includes a needlestick prevention device using PUNCTUR-GUARD® technology. The features of this device may aid in the prevention of needlestick injury. This device is intended for single use only.
JMS AV Fistula Needle Set "Wing Eater" .
Use for temporary cannulation for vascular access for extracorporeal blood treatment. This device is intended to single use only and is for temporary catheterization less than 30 days. The safety feature (foldable wing and Wing Eater) aids in prevention of needlestick injury when removing and discarding needle after dialysis session.
3. Does the device have technological characteristics that raise new types of safety or effectiveness questions?
NO - The Fresenius Punctur-Guard Fistula Needle Set has been designed to perform equivalently to standard non-blunting fistula needles.
4. Does descriptive or performance information demonstrate equivalence?
YES – Fresenius Medical Care North America believes that the information provided in this submission clearly describes the Fresenius Punctur-Guard Fistula Needle Set. and demonstrates that it is substantially equivalent to the Bio-Plexus Punctur-Guard Winged Set for Blood Collection and the JMS AV Fistula Needle Set "Wing Eater".
2
Fresenius PUNCTUR-GUARD® Fistula Needle Set 510(k) Premarket Notification
Summary of Safety and Effectiveness
F. Safety Summary
The Fresenius PUNCTUR-GUARD® Fistula Needle Set will be thoroughly tested and required to meet all final release specifications prior to distribution. The results of design verification indicate that the Fresenius PUNCTUR-GUARD® Fistula Needle Set's performance is equivalent to other fistula needles currently in commercial distribution. The results of this testing, which includes, but is not limited to: sterility, pyrogenicity, physical testing and visual examination of both in-process and finished product, indicate that the device is safe and effective for its intended use. The following testing was performed as part of design verification:
| Test | Result |
|---|---|
| ISO 10993-1 Biocompatibility | Passed |
| Sheath Removal Force | All samples passed |
| Penetration Testing | All samples passed |
| Tubing Tensile Strength | All samples passed |
| Tubing/Luer Bond Strength | All samples passed |
| Tubing/Third Wing Bond Strength | All samples passed |
| Wing Body/Third Wing Disassembly | |
| Force | All samples passed |
| Front Cannula/Wing Body Bond | |
| Strength | All samples passed |
| Blunting Member/Third Wing Bond | |
| Strength | All samples passed |
| Safety Feature Activation Torque | |
| Testing | All samples passed |
| Lock Force - Spring Arm | All samples passed |
| Positive Pressure Leak Testing | All samples passed |
| Negative Pressure Leak Testing | All samples passed |
| Tip to Tip Distance Testing | All samples passed |
| Rate Flow vs. Pressure Drop | Maximum recommended flow rate for each |
| gauge size: | |
| 17G ≤200 ml/min16G ≤300 ml/min15G ≤400 ml/min14G ≤600 ml/min |
In addition, Instructions for Use are provided, which contain instructions for proper use of the device as well as warnings and cautions.
Asta Eilifsen
Art Eilinsfeld Director of Regulatory Affairs
12/22/02
Date
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
MAR 2 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Nichole Riek Regulatory Affairs Supervisor Fresenius Medical Care North America 95 Hayden Avenue LEXINGTON MA 02420
Re: K023162
Trade/Device Name: Fresenius PUNCTUR-GUARD® Fistula Needle Set Regulation Number: 21 CFR 8876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: 78 FIE Dated: December 20, 2002 Received: December 23, 2002
Dear Ms. Riek:
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 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 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.
4
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Nancy Crogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a geometric shape resembling a funnel or inverted pyramid with horizontal lines inside. Below the shape, the text "Fresenius Medical Care" is written in a clear, sans-serif font.
Indications for Use Statement
Device Name:
Fresenius PUNCTUR-GUARD® Fistula Needle Set
Indications for Use:
The Fresenius PUNCTUR-GUARD® Fistula Needle Set is indicated for use as a non-implantable (less than 30 days use) vascular access device for temporary cannulation in procedures requiring an extracorporeal circuit. The set includes a needlestick prevention device using PUNCTUR-GUARD® technology. The features of this device may aid in the prevention of needlestick injury. This device is intended for single use only.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Nancy Brogdon
(Division Sign-Off) Division of Reproductive, A and Radiological Devi 510(k) Number .
Fresenius Medical Care North America