(113 days)
Hemodialysis with SyntraTM + dialyzers is indicated for patients with renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.
Model 200 Dialyzer
Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this is a 510(k) summary for a medical device (dialyzer) and not an AI/software-as-a-medical-device (SaMD) submission, so most of the AI-specific questions will be "N/A."
The provided document is a 510(k) Premarket Notification for the Syntra™ + Dialyzer, a conventional medical device (high permeability hemodialysis system), not a software or AI-driven device. As such, many of the requested categories related to AI/software performance, ground truth, expert review, and MRMC studies are not applicable. The acceptance criteria and "study" (validation) for this device focus on biological safety, sterilization, manufacturing quality, and functional equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biological Safety: Met the biological requirements of ISO 10993-1: Biological Evaluation of Medical devices - Part: Guidance on selection of tests. | Components of the subject Syntra™ + dialyzer have met the biological requirements of ISO 10993-1. |
| Sterilization: Validation of gamma sterilization cycle per AAMI/ISO 11137:1994 "Sterilization of Healthcare Products -- Requirements for Validation and Routine Control - Radiation Sterilization." | The validation of the gamma sterilization cycle for the Syntra™ Plus dialyzer is based upon the AAMI/ISO 11137:1994. |
| Pyrogen Testing: Meets the requirements of USP 24 <161>, Transfusion and Infusion Assemblies and Similar Medical Devices. | Pyrogen testing of the subject dialyzer meets the requirements of USP 24 <161>. |
| Particle Count: Performed per USP XXIII Monograph <788>. (Note: "For information only and is not a release criteria at this time.") | Particles are counted per USP XXIII Monograph <788>. |
| Functional Testing (Blood Side Integrity & Conformance to Manufacturing Specifications): Performed as in-process and/or final inspections prior to product release to ensure a quality product. | Functional testing for blood side integrity and conformance to manufacturing specifications are performed as in-process and/or final inspections to ensure a quality product. |
| Technological Characteristics: Similar to predicate device (Syntra™ Dialyzer, K002210) and does not raise new safety and effectiveness issues. | The general design and material of the Syntra™ + Dialyzer is similar to the Syntra™ Dialyzers cleared under K002210, and do not raise any new types of safety and effectiveness issues. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated as a single "test set" in the context of an AI device. The validation activities involve testing of device components and samples according to the referenced standards (ISO, AAMI/ISO, USP). The specific number of devices or components sampled for each test (e.g., biological testing, pyrogen testing, particle count) is not provided in this summary.
- Data Provenance: Not applicable in the context of patient data for a software/AI device. The data provenance would refer to the origin of the physical device samples used for testing (e.g., from the manufacturing line).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable (N/A). This is a hardware medical device submission. Ground truth, in the AI context of expert consensus, is not relevant here. The ground truth for device performance is based on established engineering, material, and biocompatibility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods like 2+1 or 3+1 are used in expert consensus for AI model ground truth establishment. For this physical device, conformity to standards is typically assessed against predefined pass/fail criteria established by the standards themselves, not through expert adjudication of images or outputs.
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
- N/A. MRMC studies are specific to AI-assisted human performance evaluations. This submission is for a physical dialyzer.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical hardware device; there is no algorithm to evaluate in standalone mode.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is established by compliance with recognized international and national standards for medical device safety and performance (e.g., ISO 10993-1 for biocompatibility, AAMI/ISO 11137 for sterilization, USP 24 <161> for pyrogenicity, USP XXIII Monograph <788> for particle count). Additionally, functional testing and conformance to manufacturing specifications serve as the ground truth for acceptable product quality.
8. The sample size for the training set
- N/A. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- N/A. As there is no training set, there is no ground truth for a training set to establish.
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|<023664
510(K) SUMMARY
| 510(K) SUMMARY | ||
|---|---|---|
| Submitter's Name: | David E. Curtin, RAC | FEB 21 2003 |
| Address: | 1620 Waukegan Rd. MPGR-A2E | |
| Phone: | (847) 473-6079 | |
| Fax: | (847) 473-6952 | |
| Contact: | David E. Curtin | |
| Date Prepared: | 5/14/02 | |
| Trade Name: | SyntraTM + Dialyzer | |
| Common Name: | Dialyzer | |
| Classification Name: | High Permeability Hemodialysis System per 21 CFR 876.5860 | |
| Equivalent Predicate: | SyntraTM Dialyzer (K002210) | |
| Device Description: | Model 200 Dialyzer | |
| Intended Use: | Hemodialysis with SyntraTM + dialyzers is indicated for patientswith renal failure when conservative therapy is judged to beinadequate. It also may be indicated in the treatment ofpatients intoxicated with poisons or drugs. |
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Page 2/2
510(k) Premarket Notification Syntra Plus Dialyzer Page 2 of 2
| Summary of the Technological Characteristics Compared to the Predicate Device: | The general design and material of the Syntra TM +Dialyzer is similar to the Syntra TM Dialyzers cleared underK002210, and do not raise any new types of safety andeffectiveness issues, when compared to the predicate product. |
|---|---|
| Clinical Data: | N/A |
| Conclusions Drawn | Components of the subject Syntra TM + dialyzer have met thebiological requirements of ISO 10993-1: Biological Evaluationof Medical devices - Part: Guidance on selection of tests. |
| The validation of the gamma sterilization cycle for the Syntra TMPlus dialyzer is based upon the AAMI/ISO 11137:1994"Sterilization of Healthcare Products -- Requirements forValidation and Routine Control - Radiation Sterilization". | |
| Pyrogen testing of the subject dialyzer meets the requirementsof USP 24 <161>, Transfusion and Infusion Assemblies andSimilar Medical Devices. | |
| Particles are counted per USP XXIII Monograph <788>. Thisprocedure is performed initially for information only and is nota release criteria at this time. | |
| Functional testing for blood side integrity and conformance tomanufacturing specifications are performed as in-processand/or final inspections prior to product release to ensure aquality product. | |
| Additional Information |
Requested by FDA:
None to date
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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 features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 1 2003
David E. Curtin, R.A.C. Associate Director, Regulatory Affairs Renal Division Baxter Healthcare Corporation 1620 Waukegan Road MCGAW PARK IL 60085
Re: K023664
Trade/Device Name: Syntra™ + Dialyzer Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: February 3, 2003 Received: February 4, 2003
Dear Mr. Curtin:
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.
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); 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.
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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 our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. 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 yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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Indications for Use Statement
510(k) Number (if known): K023664
Device Name: Syntra™ + Dialyzer
Indications For Use:
Hemodialysis with Syntra™ + is indicated for patients with renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
| Nancy Chogdon (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices | |
|---|---|
| G:\510k\Syntra Plus\submission\Indications for Us | |
| 510(k) Number | K023664 |
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”