(246 days)
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).
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)
This document describes a 510(k) premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and reported device performance in the way requested for AI/diagnostic devices. The information provided heavily emphasizes physical, chemical, biological, and sterilization specifications rather than clinical performance metrics often associated with "device performance" in the context of diagnostic or AI-driven tools.
Therefore, the requested table of acceptance criteria and reported device performance, and several other points (2, 3, 4, 5, 6, 7, 8, 9), cannot be directly extracted or are not applicable from the provided text in the way they would be for a typical AI/diagnostic device study. The text primarily focuses on conformity to standards and substantial equivalence.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Applicable Standards/Specifications) | Reported Device Performance (as stated in the document) |
|---|---|
| Physical Specification | Conforms to applicable standards |
| Chemical Specification | Conforms to applicable standards |
| Biological Specification | Conforms to applicable standards (including ISO 10993 series, USP Pyrogenic standards) |
| Sterilization Specification | Conforms to applicable standards (including ISO 11607-1, ISO 11135) |
| Substantial Equivalence to Predicate Device | Bench testing demonstrates that differences in technological characteristics do not raise new questions of safety or effectiveness, making it substantially equivalent to Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming set (K972206) & (K001465). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "bench testing," but it does not specify the sample size used for these tests. Data provenance (country of origin, retrospective/prospective) is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a blood tubing pack, and its evaluation relies on engineering, material, and sterility testing against established standards, not expert interpretation of outputs like an AI diagnostic tool.
4. Adjudication method for the test set
Not applicable. The evaluation is based on conformance to engineering and safety standards, not a diagnostic interpretation process requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI or diagnostic device that involves human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI algorithm. The performance evaluation focuses on the physical and biological characteristics of the blood tubing pack itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on established international and national standards for medical device safety, material compatibility, and sterilization (e.g., ISO 10993 series for biological evaluation, ISO 11607-1 for packaging, ISO 11135 for sterilization, USP Pyrogenic standards).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
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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 andA.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 andPriming 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 componentsintended to provide extracorporeal access to blood of patients suffering from endstage renal disease during Hemodialysis therapy. Each set will include anarterial/venous bloodline set, and any combination of two or three component ofthe following items:An intravenous administration set for use in administration of intravenousfluids to a dialysis set in conjunction with hemodialysis procedures. , AV fistula needle set to apply on the access site of patient vessel to draw theblood flow adequate to pass through the dialyer and reinfusion of dialysedblood back to patient vessel via the A.V. Fistula Needle Set duringhemodialysis procedures. , and/or A transducer protector for use as protective devices for pressure monitorsand 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) |
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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.
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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.
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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)
§ 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.