(29 days)
Not Found
No
The device description and intended use focus on the mechanical design and safety features of a blood access needle, with no mention of AI or ML capabilities. The performance studies compare the device to a predicate based on equivalence, not on algorithmic performance.
No.
The device is described as a "blood access device for blood purification and for other treatments requiring extracorporeal circuit," which is a device used to access the bloodstream, not to provide therapy itself. It facilitates treatment but is not a therapeutic agent.
No
The device is described as a blood access device (fistula needle) used for blood purification and other treatments requiring an extracorporeal circuit. Its primary function is to facilitate access to the bloodstream and aid in the prevention of accidental needle stick injuries, not to diagnose a condition.
No
The device description clearly states it is a sterile, single-use safety AVF needle with physical components like adapters, tubing, and a needle with a sharps safety feature. It is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a blood access device for blood purification and for other treatments requiring extracorporeal circuit." This describes a device used to access the bloodstream for therapeutic purposes, not for testing samples of blood or other bodily fluids in vitro (outside the body) to diagnose a condition.
- Device Description: The description focuses on the physical components of a needle and tubing designed for accessing blood vessels. It explicitly states it's a "non-implanted blood access device."
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any process related to diagnosing a disease or condition based on in vitro testing.
The device is clearly described as a blood access device used in procedures like blood purification (likely hemodialysis).
N/A
Intended Use / Indications for Use
The Nipro SafeTouch LOCKTAIL™ is intended for use as a blood access device for blood purification and for other treatments requiring extracorporeal circuit. The Nipro SafeTouch LOCKTAIL ™ aids in the prevention of accidental needle stick injuries. The compatibility of available configurations is the responsibility of the physician in charge."
Product codes
FIE
Device Description
The NIPRO SafeTouch LockTail™ Safety Fistula Needle is a sterile, single use, safety AVF needle. It consists of an arterial and venous adapter, flexible tube and needle with an active sharps safety feature (non-implanted blood access device) as described in 21 CFR 876.5540.
The NIPRO SafeTouch LockTail "" includes 2 basic types of designs; fixed wing type (stationary) and turnable wing type (rotating). These two designs are offered in 80 configurations with options that include needle gauge (14-18G), needle length (1" and 1 ¼"), type of needle (with or without backeye), clamp color (white, red/blue), and tubing length (150 and 300 mm).
The integrated sharps injury prevention feature requires physical action by the clinician to activate and is designed to cover the needle tip after treatment. Correct use of this anti-stick feature will eliminate accidental needlesticks.
These devices operate on the principles of a blood access device. They are sterile, single use only, non-toxic and non-pyrogenic.
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)
The results of biocompatibility data support the equivalence of the predicate device and include sterility, bacterial endotoxin, systemic injection, intracutaneous reactivity, hemolysis and implantation testing. Performance testing was also conducted and is included in this submission.
The results of the performance testing and the comparison of technological characteristics with the predicate device demonstrate that the NIPRO SafeTouch LockTail™ Safety Fistula Needle performs equivalent to the predicate device and is safe and effective when used as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 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
K093985
162
Image /page/0/Picture/1 description: The image shows the logo for Nipro Medical Corporation. The logo consists of a stylized double helix symbol on the left, followed by the word "NIPRO" in large, blocky letters. Below "NIPRO" is the phrase "MEDICAL CORPORATION" in a smaller font. The logo appears to be in black and white.
3150 NW 107th Avenue Miami FL 33172 Tel: 305.599.7174 ax: 305.592.4621
JAN 22 2010
510k Summary NIPRO SafeTouch LockTail™ Safety Fistula Needle
807.92(a)(1)
Applicant: Establishment Reg .:
Contact Person:
Nipro Medical Corporation 1056186
Jessica Oswald Regulatory Affairs Specialist
Date of summary preparation:
December 16, 2009
807.92(a)(2)
Trade Name: NIPRO SafeTouch LockTail™ Safety Fistula Needle Common Name: Safety Fistula Needle Classification Name: Blood access device and accessories Regulation Number: 21 CFR 876.5540 Panel: 78 Product code: FIE
807.92(a)(3)
Legally marketed substantial equivalent device: K032777 - NIPRO SafeTouch II Safety AVF Needle
807.92(a){4)
Description of device:
The NIPRO SafeTouch LockTail™ Safety Fistula Needle is a sterile, single use, safety AVF needle. It consists of an arterial and venous adapter, flexible tube and needle with an active sharps safety feature (non-implanted blood access device) as described in 21 CFR 876.5540.
The NIPRO SafeTouch LockTail "" includes 2 basic types of designs; fixed wing type (stationary) and turnable wing type (rotating). These two designs are offered in 80 configurations with options that include needle gauge (14-18G), needle length (1" and 1 ¼"), type of needle (with or without backeye), clamp color (white, red/blue), and tubing length (150 and 300 mm).
The integrated sharps injury prevention feature requires physical action by the clinician to activate and is designed to cover the needle tip after treatment. Correct use of this anti-stick feature will eliminate accidental needlesticks.
These devices operate on the principles of a blood access device. They are sterile, single use only, non-toxic and non-pyrogenic.
1
807.92(a)(5)
Indication for Use:
The Nipro SafeTouch LOCKTAIL™ is intended for use as a blood access device for blood purification and for other treatments requiring extracorporeal circuit. The Nipro SafeTouch LockTAIL ™ aids in the prevention of accidental needle stick injuries. The compatibility of available configurations is the responsibility of the physician in charge."
807.92(a)(6)
Comparison of technological characteristics:
The NIPRO SafeTouch LockTail™ Safety Fistula Needle is substantially equivalent to the predicate device in the following technological characteristics -
- . Design
- . Material
- Mechanical ●
- 0 Physical characteristics
- Basic Scientific Technology .
-
Intended Use
807.92(b)(1)
Non-clinical tests submitted:
The results of biocompatibility data support the equivalence of the predicate device and include sterility, bacterial endotoxin, systemic injection, intracutaneous reactivity, hemolysis and implantation testing. Performance testing was also conducted and is included in this submission.
807.92 (b)(3)
Conclusions drawn from non-clinical and clinical tests:
The results of the performance testing and the comparison of technological characteristics with the predicate device demonstrate that the NIPRO SafeTouch LockTail™ Safety Fistula Needle performs equivalent to the predicate device and is safe and effective when used as intended.
NIPRO® SafeTouch LOCKTAIL™ 5 510(k) Summary
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
JAN 2 2 2010
Ms. Jessica Oswald Regulatory Affairs Specialist Nipro Medical Corporation 3150 NW 107th Ave MIAMI FL 33172
Re: K093985 Trade/Device Name: NIPRO SafeTouch LockTail™ Safety Fistula Needle Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: FIE Dated: December 21, 2009 Received: December 24, 2009
Dear Ms. Oswald:
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.
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 of medical device-related
3
Page 2 -
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.html 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,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
-4.1-
Indications for Use
510(k) Number: K093985
Device Name: NIPRO SafeTouch LockTAIL™ Safety Fistula Needle
Indications for Use:
/
The Nipro SafeTouch LOCKTAIL™ is intended for use as a blood access device for blood purification and for other treatments requiring extracorporeal circuit. The Nipro SafeTouch LOCKTAIL ™ aids in the prevention of accidental needle stick injuries. The compatibility of available configurations is the responsibility of the physician in charge."
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use | ✓ | AND/OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
| 510(k) Number | K093985 |
|---|---|
| --------------- | ---------------------------------------------------------------------- |
NIPRO SafeTouch LOCKTAIL™
4 Indications for Use
Concurrence of CDRH, Office of Device Evaluation (ODE)