(246 days)
No
The device description and intended use clearly define the product as a set of disposable components for hemodialysis, with no mention of any computational or analytical capabilities that would involve AI or ML.
Yes.
The device is intended to provide extracorporeal access to blood of patients suffering from end stage renal disease during Hemodialysis therapy, which is a therapeutic procedure.
No
The device is described as single-use disposable components for providing extracorporeal access to blood during hemodialysis therapy, which is a treatment procedure, not a diagnostic one.
No
The device description clearly outlines physical components such as blood tubing sets, needles, and transducer protectors, which are hardware.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing "extracorporeal access to blood of patients suffering from end stage renal disease during Hemodialysis therapy." This describes a device used on the patient to facilitate a medical procedure (hemodialysis), not a device used to test samples outside the body to diagnose or monitor a condition.
- Device Description: The description details components like bloodlines, needles, and administration sets, all of which are used for directly handling blood flow during a medical procedure. There is no mention of reagents, assays, or any components typically associated with laboratory testing of samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing diagnostic or monitoring information based on sample analysis
The device is a medical device used for a therapeutic procedure (hemodialysis), not a diagnostic test.
N/A
Intended Use / Indications for Use
The BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs ( BT-102DA · BT-102DB · BT-102DC · BT-102DD) are sets of single-use disposable components intended to provide extracorporeal access to blood of patients suffering from end stage renal disease during Hemodialysis therapy. Each set will include an arterial/venous bloodline set, and any combination of two or three component of the following items:
← An intravenous administration set for (use in administration of intravenous fluids to a dialysis set in conjunction with hemodialysis procedures.) ,
· AV fistula needle set to (apply on the access site of patient vessel to draw the blood flow adequate to pass through the dialyer and reinfusion of dialysed blood back to patient vessel via the A.V. Fistula Needle Set during hemodialysis procedures.) , and/or
← A transducer protector for (use as protective devices for pressure monitors and to help protect the sterility of the fluid pathway).
Product codes
78 FJK
Device Description
The BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs (BT-102DA 、BT-102DB、BT-102DC、BT-102DD) are sets of single-use disposable components intended to provide extracorporeal access to blood of patients suffering from end stage renal disease during Hemodialysis therapy. Each set will include an arterial/venous bloodline set, and any combination of two or three component of the following items:
An intravenous administration set for use in administration of intravenous fluids to a dialysis set in conjunction with hemodialysis procedures. , AV fistula needle set to apply on the access site of patient vessel to draw the blood flow adequate to pass through the dialyer and reinfusion of dialysed blood back to patient vessel via the A.V. Fistula Needle Set during hemodialysis procedures. , and/or A transducer protector for use as protective devices for pressure monitors and to help protect the sterility of the fluid pathway. BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs includes 4 models (BT-102DA 、BT-102DB、BT-102DC、BT-102DD)
BT-102DA BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Pack consists of three components: a BIOTEQ® Hemodialysis Blood Tubing Set, a BIOTEQ® I.V.(INTRAVENOUS) SET, and a TRANSDUCER PROTECTOR.
BT-102DB BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Pack consists of three components: a BIOTEO® Hemodialysis Blood Tubing Set, a BIOTEO® A.V.F.FISTULA NEEDLE SET, and a TRANSDUCER PROTECTOR
→ BT-102DC BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Pack consists of four components : a BIOTEQ® Hemodialysis Blood Tubing Set , a BIOTEQ® I.V.(INTRAVENOUS) SET , a BIOTEQ® A.V.F.FISTULA NEEDLE SET, and a TRANSDUCER PROTECTOR.
BT-102DD BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Pack consists of three components: a BIOTEQ® Hemodialysis Blood Tubing Set , a BIOTEQ® I.V.(INTRAVENOUS) SET , and a BIOTEQ® A.V.F.FISTULA NEEDLE SET.
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)
Performance Summary: In terms of Physical specification, Chemical specification, Biological specification & Sterilization Specification, the device conforms to applicable standards included ISO 10993 series, ISO 11607-1, ISO 11135, USP Pyrogenic standards & related standards ------- etc. 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)
Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming set (K972206) & (K001465)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
510(K) SUMMARY JUL - 9 2002
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: | 8 F-3, No. 136, Sec.3,Jen-Ai Road, Taipei, Taiwan, R.O.C. | |
| Phone: | 886-2-2708-3188 | |
| Fax: | 886-2-2707-6610 | |
| Contact: | Mr. William Lee (General Manager) | |
| 2. | Device Name | |
| Trade Name: | BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Pack | |
| Common Name: | Blood Tubing Set With Transducer Protector , I.V.(INTRAVENOUS) SET and | |
| A.V.F.FISTULA NEEDLE SET | ||
| Classification name: | ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS | |
| 3. | Classification: | Class II |
| Predicate Device: | Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and | |
| Priming set (K972206) & (K001465) | ||
| 5. | Device Description: | The BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs (BT-102DA 、BT- |
| 102DB、BT-102DC、BT-102DD) are sets of single-use disposable components | ||
| intended to provide extracorporeal access to blood of patients suffering from end | ||
| stage renal disease during Hemodialysis therapy. Each set will include an | ||
| arterial/venous bloodline set, and any combination of two or three component of | ||
| the following items: | ||
| An intravenous administration set for use in administration of intravenous | ||
| fluids to a dialysis set in conjunction with hemodialysis procedures. , AV fistula needle set to apply on the access site of patient vessel to draw the | ||
| blood flow adequate to pass through the dialyer and reinfusion of dialysed | ||
| blood back to patient vessel via the A.V. Fistula Needle Set during | ||
| hemodialysis procedures. , and/or A transducer protector for use as protective devices for pressure monitors | ||
| and to help protect the sterility of the fluid pathway. BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs includes 4 models (BT- | ||
| 102DA 、BT-102DB、BT-102DC、BT-102DD) |
1
2 of 2
BT-102DA BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Pack consists of three components: a BIOTEQ® Hemodialysis Blood Tubing Set, a BIOTEQ® I.V.(INTRAVENOUS) SET, and a TRANSDUCER PROTECTOR.
BT-102DB BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Pack consists of three components: a BIOTEO® Hemodialysis Blood Tubing Set, a BIOTEO® A.V.F.FISTULA NEEDLE SET, and a TRANSDUCER PROTECTOR
→ BT-102DC BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Pack consists of four components : a BIOTEQ® Hemodialysis Blood Tubing Set , a BIOTEQ® I.V.(INTRAVENOUS) SET , a BIOTEQ® A.V.F.FISTULA NEEDLE SET, and a TRANSDUCER PROTECTOR.
BT-102DD BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Pack consists of three components: a BIOTEQ® Hemodialysis Blood Tubing Set , a BIOTEQ® I.V.(INTRAVENOUS) SET , and a BIOTEQ® A.V.F.FISTULA NEEDLE SET.
The BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs ( BT-102DA · BT-Intended Use: 6. 102DB · BT-102DC · BT-102DD) are disposable bloodlines intended to provide extracorporeal access to the patient's blood during Hemodialysis therapy. The compatibility of available configurations is the responsibility of the physician in charge.
Performance Summary: In terms of Physical specification, Chemical specification, Biological specification & Sterilization Specification, the device conforms to applicable standards included ISO 10993 series, ISO 11607-1, ISO 11135, USP Pyrogenic standards & related standards ------- etc.
Conclusions: 8.
The BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs have the same intended use and similar technological characteristics as the Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming set (K972206) & (K001465). 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 BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or other bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
9 2002 JUL
BIOTEQUE CORPORATION c/o Ms. Jennifer Reich Harvest Consulting, Inc. 3892 South America West Trail FLAGSTAFF AZ 86001
Re: K013634
.
Trade/Device Name: BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Pack Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 FJK Dated: April 6, 2002 Received: April 10, 2002
Dear Ms. Reich:
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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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.
3
Page 2 - Ms. Jennifer Reich
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 (21 CFR Part 807); 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.
This letter will allow you to begin marketing your device as described in your Section 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 the labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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 vours.
David A. Lyman
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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510 (k) NUMBER (IF KNOWN): BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs DEVICE NAME: BIOTEQUE CORPORATION
INDICATIONS FOR USE:
The BIOTEQ® 3 in 1 Hemodialysis Blood Tubing Packs ( BT-102DA · BT-102DB · BT-102DC · BT-102DD) are sets of single-use disposable components intended to provide extracorporeal access to blood of patients suffering from end stage renal disease during Hemodialysis therapy. Each set will include an arterial/venous bloodline set, and any combination of two or three component of the following items:
← An intravenous administration set for (use in administration of intravenous fluids to a dialysis set in conjunction with hemodialysis procedures.) ,
· AV fistula needle set to (apply on the access site of patient vessel to draw the blood flow adequate to pass through the dialyer and reinfusion of dialysed blood back to patient vessel via the A.V. Fistula Needle Set during hemodialysis procedures.) , and/or
← A transducer protector for (use as protective devices for pressure monitors and to help protect the sterility of the fluid pathway).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Deyice Evaluation
Daniel G. Dygert
510k) Nu
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)