(162 days)
The BIOTEQUE Hemodialysis Blood Tubing Set(Models BT-102A, BT-102B and BT-190) is intended to serve as a conduit through which blood is taken from the patient, delivered to the dialyzer, and returned to the patient during hemodialysis therapy. The device is intended to be used for patients suffering from renal disease only.
Bioteque Hemodialysis Blood Tubing Set, consists of Arterial Line & Venous Line, is used as the conduit through which blood is taken from the patient, delivered to the dialyzer, and returned to the patient during dialysis therapy.
The provided text for the BIOTEQUE HEMODIALYSIS BLOOD TUBING SET (K992930) discusses performance in terms of adherence to various standards rather than specific quantitative acceptance criteria and device performance values. It is a submission for a medical device that outlines its equivalence to a predicate device based on similar intended use and technological characteristics. The document does not describe a study comparing the device's performance against specific, pre-defined quantitative acceptance criteria in a clinical setting in the way an AI/ML device would be.
Therefore, many of the requested categories for AI/ML device studies (such as sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this 510(k) summary for a physical medical device.
However, I can extract the information that is present and indicate where the requested information is not provided or applicable.
Acceptance Criteria and Device Performance for BIOTEQUE HEMODIALYSIS BLOOD TUBING SET (K992930)
This 510(k) summary for the BIOTEQUE HEMODIALYSIS BLOOD TUBING SET does not present quantitative acceptance criteria or corresponding device performance results in the format typically seen for AI/ML diagnostic devices. Instead, the performance is demonstrated through conformance to established national and international standards for physical medical devices. The core argument for acceptance is substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Standards Complied With) | Reported Device Performance (Conformance) |
|---|---|
| Physical Specification | Conforms to applicable standards |
| Chemical Specification | Conforms to applicable standards |
| Biological Specification | Conforms to applicable standards (e.g., ISO 10993 series, USP Pyrogenic standards) |
| Sterilization Specification | Conforms to applicable standards (e.g., ISO 11607-1, ISO 11135) |
| Intended Use | Same as predicate device |
| Technological Characteristics | Similar to predicate device |
Study Proving Device Meets Acceptance Criteria:
The study described is primarily a bench testing and comparison to predicate device approach, rather than a clinical trial with quantitative endpoints in the context of AI/ML performance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document refers to "bench testing," which implies laboratory-based evaluations of the physical device components. Specific sample sizes for these tests are not provided in this summary.
- Data Provenance: Not applicable in the context of patient data for an AI/ML device. The testing would have been conducted in a laboratory setting by the manufacturer, BIOTEQUE CORPORATION, likely in Taiwan (R.O.C.), given the submitter's address.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable: This type of information is relevant for studies involving human interpretation (e.g., radiologists reviewing images to establish ground truth). For a physical medical device like blood tubing, "ground truth" is typically established through validated laboratory tests against defined physical, chemical, and biological specifications, not through expert consensus on observational data.
4. Adjudication Method for the Test Set
- Not Applicable: Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human reviewers (experts) when establishing ground truth from observational data. This is not relevant for bench testing of a physical product.
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 a physical medical device (blood tubing), not an AI/ML diagnostic algorithm. Therefore, an MRMC study and the concept of human reader improvement with/without AI assistance do not apply.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Standards Conformance: The "ground truth" for this device is based on conformance to established national and international standards for medical device physical, chemical, biological, and sterilization properties (e.g., ISO 10993 series, ISO 11607-1, ISO 11135, USP Pyrogenic standards). The absence of safety and effectiveness concerns compared to a predicate device (K853851) also serves as a benchmark for acceptability.
8. The Sample Size for the Training Set
- Not Applicable: This is a physical medical device. There is no "training set" in the context of an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: As there is no training set, the establishment of ground truth for it is not relevant.
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510(K) SUMMARY 9 2000 FEB
.his summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
- 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 HEMODIALYSIS BLOOD TUBING SET |
|---|---|
| Common Name: | HEMODIALYSIS BLOOD TUBING SET |
| Classification name: | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE |
- Classification:
| Classification: | Class II |
|---|---|
| ----------------- | ---------- |
- Predicate Device:
| Predicate Device: | FRESENIUS DISPOSABLE BLOOD LINES (K853851) |
|---|---|
| ------------------- | -------------------------------------------- |
- Device Description:
| Device Description: | Bioteque Hemodialysis Blood Tubing Set, consists of Arterial Line & Venous Line, is used as the conduit through which blood is taken from the patient, delivered to the dialyzer, and returned to the patient during dialysis therapy. |
|---|---|
| --------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
- Intended Use:
| Intended Use: | INTENDED USE:The BIOTEQUE Hemodialysis Blood Tubing Set(Models BT-102A, BT-102B and BT-190) is intended to serve as a conduit through which blood is taken from the patient, delivered to the dialyzer, and returned to the patient during hemodialysis therapy. The device is intended to be used for patients suffering from renal disease only.USERS TO INSTALL THE DEVICE:Trained nurses or the doctors.ENVIRONMENT FOR THE DEVICE TO BE USED:The hemodialysis center.SPECIAL NOTES:The hemodialysis blood tubing sets must be installed by trained nurses and doctors.The patients can not influence the use of the device. |
|---|---|
| --------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
FDA 510(K) SUMMARY 【A2】 Page Revision
Page 1 of 2
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- 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.
8. Conclusions:
The BIOTEQUE HEMODIALYSIS BLOOD TUBING SET have the same intended use and similar technological characteristics as the FRESENIUS DISPOSABLE BLOOD LINES ( K853851 ). 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 HEMODIALYSIS BLOOD TUBING SET is substantially equivalent to the predicate devices.
FDA 510(K) SUMMARY
Page Revision 【A2】
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
9 2000 FEB
Bioteque Corporation c/o Mr. Allen Reich Harvest Consulting, Inc. 900 N. Switzer Canyon Dr., #142 Flaggstaff, AZ 86001
Re: K992930
Bioted® Hemodialysis Blood Tubing Sets Models BT-102A; BT-102B; and, BT-190 Dated: December 11, 1999 Received: December 14, 1999 Regulatory Class: II 21 CFR §876.5820/Procode: 78 FJK
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). 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 major requlations affecting your device can be found in the Code of Federal Reculations, 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)
BIOTEQ Hemodialysis Blood Tubing Set DEVICE NAME: BIOTEQUE CORPORATION
INDICATIONS FOR USE:
The BIOTEQ Hemodialysis Blood Tubing Set (Models BT-102A, BT-102B, and BT-190) is intended to serve as a conduit through which blood is taken from the patient, delivered to the dialyzer, and returned to the patient during hemodialysis therapy. The device is intended to be used for patients suffering from renal disease only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation |
|---|
| -------------------------------------------------- |
| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter (Optional Format) |
|---|---|
| --------------------------------------- | --------------------------------------- |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K992930 |
|---|---|
| --------------- | --------- |
§ 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.