(88 days)
Not Found
No
The device description and intended use clearly describe a physical medical device (a needle set) used for hemodialysis, with no mention of software, algorithms, or any AI/ML related terms or functionalities.
No
This device is an accessory for an extracorporeal system used in hemodialysis. While essential for the procedure, it acts as a conduit for blood flow rather than actively treating the renal failure itself.
No
Explanation: The Bioteque A.V. Fistula Needle is described as a device used during hemodialysis to obtain and return blood flow, and its components are entirely mechanical. There is no mention of it collecting data, analyzing conditions, or providing diagnostic information.
No
The device description clearly lists multiple physical components (stainless needle, protector cap, plastic butterfly wing, PVC tubing, female luer, cap for female luer) that are assembled together. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to access a patient's blood vessel for hemodialysis, which is a treatment procedure. It is not used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The device is a needle set designed for physical access to the bloodstream. It does not contain reagents, calibrators, or controls typically associated with IVD devices.
- Lack of IVD-related information: The document does not mention any aspects related to in vitro testing, sample analysis, or diagnostic information.
Therefore, the Bioteque A.V. Fistula Needle is a medical device used for a therapeutic procedure (hemodialysis), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Bioteque A.V. Fistula Needle is used during hemodialysis. It's a part of accessory of extracorporeal system for treatment of renal failure. A.V. Fistula Needle applied on the access site of patient's vessel to obtain blood flow adequate to pass through the dialyses, and the reinfusion of dialysed blood back to patient via the fistula needle during hemodialysis.
Bioteque A.V. fistula needle set consist of a fistula needle which inserted into the site of patient's vessel to obtain blood flow adequate to pass through the dialyser and the reinfusion of dialysed blood back to patient via the fistula needle during hemodialysis .
Product codes
78 FIE
Device Description
Bioteque A.V. Fistula Needle Set consist of the following major components: the stainless needle, protector cap for needle, the plastic butterfly wing, the PVC tubing, the female luer, the cap for female luer. These 6 major components assembled together as A.V. Fistula Needle Set for use during hemodialysis procedures. Various models of needle size manufactured such as 14 gauge, 15 gauge, 16 gauge.
Bioteque A.V. fistula needle consists a large-bore (14-16-gauge) steel needle with plastic wing handle follow extension tubing and small clamp, the end of rotation female luer lock is for universal used to connect blood tubing. It's not implantable device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vessel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained nurses or the doctors.
The hemodialysis center.
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)
bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness.
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
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
DEC 17 1999
510(K) SUMMARY
K993118
Page 1 of 2
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
| 1. | Submitter's Name: | BIOTEQUE CORPORATION |
|---|---|---|
| Address: | Suite 402, 4th Fl, No. 136, Sec.3,Jen-Ai Road, Taipei, R.O.C. | |
| Phone: | 886-2-2708-6716 | |
| Fax: | 886-2-2707-6610 | |
| Contact: | Mr. William Lee (General Manager) |
-
- Device Name
Trade Name: BIOTEQUE A.V. FISTULA NEEDLE SET A.V. FISTULA NEEDLE SET Common Name: Classification name: NEEDLE, FISTULA
- Device Name
-
- Classification: Class II Panel: Product Code: 78 FIE
Predicate Device: TERUMO AV FISTULA NEEDLE SET 4. ( K891062 )
- Classification: Class II Panel: Product Code: 78 FIE
న. Device Description: BIOTEQUE A.V. FISTULA NEEDLE SET
Bioteque A.V. Fistula Needle Set consist of the following ર major components: the stainless needle, protector cap for needle, the plastic butterfly wing, the PVC tubing, the female luer, the cap for female luer. These 6 major components assembled together as A.V. Fistula Needle Set for use during hemodialysis procedures. Various models of needle size manufactured such as 14 gauge, 15 gauge, 16 gauge.
- INTENDED USE: 6. Intended Use: Bioteque A.V. Fistula Needle is used during hemodialysis. It's a part of accessory of extracorporeal system for treatment of renal failure. A.V. Fistula Needle applied on the access site of patient's vessel to obtain blood flow adequate to pass through the dialyses, and the reinfusion of dialysed blood back to patient via the fistula needle during hemodialysis.
- USERS TO INSTALL THE DEVICE:
Trained nurses or the doctors.
Page 1 of 2
【A1】 FDA 510/K) SUMMARY Page Revision
1
ENVIRONMENT FOR THE DEVICE TO BE USED: The hemodialysis center. SPECIAL NOTES: The Arterial - Venous Fistula ( A.V.F.) Needle Set must be installed by trained nurses and doctors. The patients can not influence the use of the device. In terms of Physical specification, Chemical specification, Biological specification & 7. Performance Sterilization specification, the device conforms to applicable standards included ISO Summary: 10993 series, ISO 11607-1, ISO 11135, USP Pyrogenic standards & related standards --etc.
8. Conclusions:
The BIOTEQUE A.V. FISTULA NEEDLE SET have the same intended use and similar technological characteristics as the TERUMO AV FISTULA NEEDLE SET ( K891062 ). Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the BIOTEQUE A.V. FISTULA NEEDLE SET is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is in a bold, sans-serif font. The text is black and the background is white. The text is centered in the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 1999
BIOTEQ® CORPORATION c/o Mr. Allen Reich Harvest Consulting, Inc. 900 N. Switzer Canyon Drive, #142 Flaggstaff, AZ 86001
Re: K993118
Bioteque A.V. Fistula Needle Set Dated: September 20, 1999 Received: September 20, 1999 Requiatory Class: II 21 CFR 876.5540/Procode: 78 FIE
Dear Mr. Reich:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (Premarket Approval), it may be subject to such additional controls. Existing maior requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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NUMBER (IF KNOWN): 510 (k)
BIOTEQUE A.V. FISTULA NEEDLE SET DEVICE NAME: BIOTEQUE CORPORATION
INDICATIONS FOR USE:
Bioteque A.V. fistula needle set consist of a fistula needle which inserted into the site of patient's vessel to obtain blood flow adequate to pass through the dialyser and the reinfusion of dialysed blood back to patient via the fistula needle during hemodialysis .
· FEATURE:
Bioteque A.V. fistula needle consists a large-bore (14-16-gauge) steel needle with plastic wing handle follow extension tubing and small clamp, the end of rotation female luer lock is for universal used to connect blood tubing. I It's not implantable device.
· USERS TO INSTALL THE DEVICE: Trained nurses or the doctors.
· ENVIRONMENT FOR THE DEVICE TO BE USED:
The hemodialysis center.
· SPECIAL NOTES:
The Arterial - Venous Fistula ( A.V.F.) Needle Set must be installed by trained nurses and doctors. The patients can not influence the use of the device.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices. | |
| 510(k) Number | K993118 |
| Prescription Use (Per 21 CFR 801.109) | X |
| OR | Over-The-Counter |