(158 days)
The NovaLine SP-C35 Transducer Protector is a single-use, disposable, prescription device intended for use as a protective device for pressure monitors and to help prevent contamination of the fluid pathway in hemodialysis delivery systems.
The NovaLine SP-C35 Transducer Protector consists of a plastic housing that contains a hydrophobic filter with a reference pore size of 0.2 µ m. The housing has male and female luer lock connectors that allow its attachment between a blood tubing set and the pressure monitor on a hemodialysis machine.
The NovaLine SP-C35 Transducer Protector is to be used as protective device for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.2 ↓ m hydrophobic filter helps prevent cross-contamination by viruses, bacterial and particulate matter while preventing the flow of fluids to the hemodialysis machine pressure monitor.
The devices are packaged sterile and labeled for single use only.
The proposed devices are provided in sterile condition, it is subject to e-beam radiation sterilization prior to release to achieve a Sterility Assurance Level (SAL) of 10-6.
Here's a breakdown of the acceptance criteria and study information for the NovaLine SP-C35 Transducer Protector based on the provided FDA 510(k) summary.
Note: This document describes a medical device, not an AI or software-based medical device. Therefore, many of the requested fields related to AI performance, ground truth, and expert evaluation are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
Device: NovaLine SP-C35 Transducer Protector
| Acceptance Criteria Category | Specific Test / Characteristic | Acceptance Criteria (Target) | Reported Device Performance (Result) | Relevant Standard (if applicable) |
|---|---|---|---|---|
| Physical Performance | Appearance | Complies with specifications | Complies with specifications | --- |
| Structural Integrity | Maintained | Maintained | --- | |
| Dimension | Complies with standard | Complies with standard | ISO 80369-7:2021 | |
| Sterility | SAL of 10^-6 | Achieved SAL of 10^-6 | --- | |
| Positive Pressure Limitation | 500 mmHg | 500 mmHg (matches predicate) | --- | |
| Negative Pressure Limitation | -500 mmHg | -500 mmHg (matches predicate) | --- | |
| Connections Conformance | Conforms to standard | Conforms to standard | ISO 80369-7:2016 | |
| Biocompatibility | Cytotoxicity | Non-toxic | Complies with ISO 10993-5 | ISO 10993-5 |
| Sensitization | Non-sensitizing | Complies with ISO 10993-10 | ISO 10993-10 | |
| Irritation/Intradermal Reactivity | Non-irritating | Complies with ISO 10993-23 | ISO 10993-23 | |
| Systemic Toxicity/Acute Systemic Toxicity | Non-toxic | Complies with ISO 10993-11 | ISO 10993-11 | |
| Pyrogens/Material-mediated Pyrogens | Non-pyrogenic | Complies with ISO 10993-11 | ISO 10993-11 | |
| In Vitro Hemolysis | Non-hemolytic | Complies with ISO 10993-4 | ISO 10993-4 | |
| Complement Activity | No adverse complement activity | Complies with ISO 10993-4 | ISO 10993-4 | |
| Partial Thromboplastin Time | No adverse effect | Complies with ISO 10993-4 | ISO 10993-4 | |
| Platelet Count | No adverse effect | Complies with ISO 10993-4 | ISO 10993-4 | |
| Hematology | No adverse effect | Complies with ISO 10993-4 | ISO 10993-4 | |
| Sterilization | Sterility Assurance Level | SAL of 10^-6 | Achieved SAL of 10^-6 | --- |
| Packaging | Seal Strength | Complies with standard | Complies with standard | ASTM F88/F88-15 |
| Dye Penetration | Complies with standard | Complies with standard | ASTM F1929-15 | |
| Shelf Life | Packaging Performance (aged samples) | Complies with acceptance criteria | Complies with acceptance criteria | ISO 80369-7 (for connections) |
| Performance Tests (aged samples) | Complies with acceptance criteria | Complies with acceptance criteria | --- | |
| Microbiological | Bacterial Endotoxin | <20 USP EU | Complies with limit | USP <85> |
| Microbial Challenge | Sterile Barrier Integrity | Maintains sterile barrier | Complies with standards | ASTM F1671/F1671M-2022, YYT1497-2016, ASTM F838-2020 |
| Distribution Simulation | Withstands distribution stresses | Complies with standard | Complies with standard | ASTM D4169-22 |
| Comparative Performance | Overall performance vs. predicate | Equivalent | Equivalent to predicate device | --- |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test within the finished product performance, packaging, or shelf-life evaluations. It mentions "proposed devices" were tested, implying a statistical sample was used according to the relevant standards, but the specific number is not provided.
Data Provenance: The tests were conducted by Bain Medical Equipment (Guangzhou) Co., Ltd. in China. The data is retrospective in the sense that the testing was performed on manufactured devices to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not Applicable. This is a medical device (transducer protector) and not an AI/software device. The "ground truth" here refers to the physical and biological properties of the device, established through standardized laboratory testing, not human expert interpretation of data.
4. Adjudication Method for the Test Set
Not Applicable. As this is not an AI/software device involving human interpretation, there is no adjudication method in the traditional sense. Device performance is determined by objective, measurable laboratory tests against pre-defined specifications and standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for imaging or diagnostic AI, comparing human readers with and without AI assistance. This device is a component of a hemodialysis system, and its performance is assessed through physical, chemical, and biological testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This device is hardware, not an algorithm or software.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Standardized Test Results: Objective measurements from various laboratory tests (e.g., dimensional measurements, sterile barrier integrity, biocompatibility assays).
- Compliance with Recognized Standards: Adherence to international and national standards such as ISO 80369-7, ISO 10993 series, ASTM F88, ASTM F1929, ASTM D4169, USP <85>, ASTM F1671, etc.
- Predicate Device Equivalence: Direct comparison to the performance characteristics of a legally marketed predicate device (Nipro Transducer Protector TP-SURE, K072988) where applicable.
8. The Sample Size for the Training Set
Not Applicable. This is a physical medical device, not an AI/machine learning model, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. See response to #8.
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Image /page/0/Picture/0 description: The image contains the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 28, 2024
Bain Medical Equipment (Guangzhou) Co., Ltd. Zoe Zeng Regulatory Supervisor No.10 Juncheng Road, No.10, Juncheng Road, Eastern Area, Economic and Technological Development Guangzhou, Guangdong 510760 China
Re: K240164
Trade/Device Name: NovaLine SP-C35 Transducer Protector Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FIB Dated: May 31, 2024 Received: May 31, 2024
Dear Zoe Zeng:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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; medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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3
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Maura Rooney -S
Maura Rooney Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K240164
Device Name NovaLine SP-C35 Transducer Protector
Indications for Use (Describe)
The NovaLine SP-C35 Transducer Protector is a single-use, disposable, prescription device intended for use as a protective device for pressure monitors and to help prevent contamination of the fluid pathway in hemodialysis delivery systems.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
ﻧﻬﺎﻳﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
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Tab #29 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K240164
-
- Date of Preparation: 05/31/2024
-
- Sponsor Identification
Bain Medical Equipment (Guangzhou) Co., Ltd.
No.10, Juncheng Road, Eastern Area, Economic and Technological Development District, 510760, Guangdong, P.R.China
Establishment Registration Number: 3013217742
Contact Person: Sophia Shao Position: Management Representative Tel: +86-20-66856868 ext. 218 Fax: +86-20-32067500 Email: sophia@baingz.com
3. Designated Submission Correspondent
Bain Medical Equipment (Guangzhou) Co., Ltd
No.10, Juncheng Road, Eastern Area, Economic and Technological Development District, 510760, Guangdong, P.R.China
Ms. Zoe Zeng (Primary Contact Person) Tel: +86-20-66856868 ext.290 Fax: +86 20 3206 7500 Email: zoe@baingz.com
Ms. Sophia Shao (Alternative Contact Person) Tel: +86-20-66856868 ext.218 Fax: +86 20 3206 7500 Email: sophia@baingz.com
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Trade Name: NovaLine SP-C35 Transducer Protector Common Name: Transducer Protector Models: 956007
Regulatory Information
Regulation Name: Hemodialysis system and accessories Classification: II Product Code: FIB Regulation Number: CFR 876.5820 Review Panel: Gastroenterology/Urology
Indications for Use:
The NovaLine SP-C35 Transducer Protector is a single-use, disposable, prescription device intended for use as a protective device for pressure monitors and to help prevent contamination of the fluid pathway in hemodialysis delivery systems.
Device Description
The NovaLine SP-C35 Transducer Protector consists of a plastic housing that contains a hydrophobic filter with a reference pore size of 0.2 µ m. The housing has male and female luer lock connectors that allow its attachment between a blood tubing set and the pressure monitor on a hemodialysis machine.
The NovaLine SP-C35 Transducer Protector is to be used as protective device for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.2 ↓ m hydrophobic filter helps prevent cross-contamination by viruses, bacterial and particulate matter while preventing the flow of fluids to the hemodialysis machine pressure monitor.
The devices are packaged sterile and labeled for single use only.
The proposed devices are provided in sterile condition, it is subject to e-beam radiation sterilization prior to release to achieve a Sterility Assurance Level (SAL) of 10-6.
| Components | Material | Type of Contact | Contact Duration | Applicable standard |
|---|---|---|---|---|
| Cap | Polyethylene | Surface device (skin) | <24 hours | ISO 10993 |
| Female luer lock connector | Polyvinylchloride | External communication device (blood path, indirect) | <24 hours | ISO 10993 |
| Male luer lock | Polyvinylchloride | External communication device (blood path, indirect) | <24 hours | ISO 10993 |
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| Filter paper | PTFE compositemembrane | External communication device(blood path, indirect) | <24 hours | ISO 10993 |
|---|---|---|---|---|
| -------------- | ---------------------------- | --------------------------------------------------------- | ----------- | ----------- |
ട. Identification of Predicate Device
Predicate Device
510(k) Number: K072988
Product Name: Nipro Transducer Protector TP-SURE Manufacturer: NIPRO MEDICAL CORPORATION
6. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.
Finished Product Performance Test
The proposed devices were tested with appearance, structural integrity, Dimension(ISO 80369-7:2021) and sterility and the test results demonstrated that the proposed device complies with the standards requirements. A side-by-side parallel test with the predicate device demonstrate that the proposed device performs equivalent to the predicate device and is safe and effective when used as intended. A human factors assessment was conducted to demonstrate its safe and effective use.
Product Packaging
Tests were performed on sterilized product packages according to ASTM F88/F88-15 and ASTM F1929-15 to support compliance with pre-established acceptance criteria.
Simulated Distribution Test
Tests were conducted according to ASTM D4169-22 to support compliance with pre-established acceptance criteria.
Shelf life
Packaging performance(Seal Strength and Dye Penetration) and Performance Tests were conducted, including tests per ISO 80369-7. The test resulted demonstrated that the accelerated aged samples complied with the pre-established acceptance criteria.
Bacterial Endotoxin Testing
Endotoxin limit is established as 20 USP Endotoxin Unit (EU) for the proposed device. Test has been conducted by Limulus Amebocyte Lysate (LAL) method according to USP <85> Bacterial Endotoxin Limit.
Biocompatibility Tests
The following tests were conducted to support the biological safety of the proposed device: cytotoxicity(ISO10993-5), sensitization(ISO 10993-10), irritation(ISO 10993-23), systemic
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toxicity(ISO10993-11), pyrogen(ISO10993-11), complement activity (ISO10993-4), partial thromboplastin time(ISO 10993-4), platelet count(ISO 10993-4) and hematology(ISO 10993-4).
Microbial Challenge Testing
Tests were conducted to support the sterile barrier according to ASTM F1671/F1671M-2022, YYT1497-2016 and ASTM F838-2020.
Electrical Safety and EMC Not applicable.
Software Verification and Validation Testing Not applicable.
Animal Studies No animal studies were performed.
7. Clinical Test Conclusion
No clinical study is included in this submission.
Substantially Equivalent (SE) Comparison 8.
| Item | Proposed Device | Predicate DeviceK072988 |
|---|---|---|
| Model | 956007 | / |
| Device Class | II | II |
| Product Code | FIB | FIB |
| Regulation Number | 21CFR part 876.5820 | 21CFR part 876.5820 |
| Indications for Use | The NovaLine SP-C35 Transducer Protectoris a single-use, disposable, prescription deviceintended for use as a protective device forpressure monitors and to help preventcontamination of the fluid pathway inhemodialysis delivery systems. | The Nipro Transducer ProtectorTP-SURE is a single-use,disposable, prescription deviceintended for use as a protectivedevice for pressure monitorsand to help preventcontamination of the fluidpathway in hemodialysisdelivery systems. |
| Feature | SterileNon-pyrogenicSingle UsePrescription Device | SterileNon-pyrogenicSingle UsePrescription Device |
| Main Configuration | Filter PaperMale Luer Lock Connector | Filter PaperMale Luer Lock Connector |
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| Item | Proposed Device | Predicate DeviceK072988 | |
|---|---|---|---|
| Cap | Cap | ||
| Physicalperformance | PositivepressureLimitation(mmHg) | 500 | 500 |
| NegativePressureLimitation(mmHg) | -500 | -500 | |
| Performance | Conforms toISO 80369-7:2016 | Conforms toISO 80369-7:2016 | |
| Materials | PVC, PTFE, PET, PE | PP, PTFE, PET | |
| Biocompatibility | Cytotoxicity;Skin Sensitization;Intradermal Reactivity;Acute Systemic Toxicity;Material-mediated Pyrogens;In Vitro Hemolysis;Bacterial endotoxin testing;Complement Activity;Partial Thromboplastin Time;Platelet Count;Hematology | Cytotoxicity;PyrogenicityAcute Toxicity;Intracutaneous Reactivity;Hemolysis Testing;Implantation Testing;Bacterial Endotoxin Testing | |
| Sterilization | Ebeam, SAL(10-6) | EO, SAL(10-6) | |
| Labeling | Direction for UseIntended UseDescriptionWarnings and Cautions | Direction for UseIntended UseDescriptionWarnings and Cautions |
The proposed device has the similar configuration, indication for use and safety feature as the predicated device. The non-clinical testing demonstrates the product performance of proposed device is similar as that of the predicate device or the product performance of proposed device is acceptable. The biocompatibility of the proposed device comply with ISO 10993 series standards.
9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.
§ 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.