(158 days)
Not Found
No
The device description and performance studies focus on the physical components and filtration capabilities, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is intended to prevent contamination and protect equipment, not to directly treat a disease or condition in a patient.
No
Explanation: The NovaLine SP-C35 Transducer Protector is described as a protective device for pressure monitors and to help prevent contamination, functioning as a filter. It does not mention any diagnostic capabilities such as detecting, identifying, or analyzing a disease or condition.
No
The device description clearly outlines a physical, disposable component with a plastic housing and a hydrophobic filter. The performance studies focus on physical properties, sterility, and biocompatibility, with "Software Verification and Validation Testing" explicitly marked as "Not applicable."
Based on the provided information, the NovaLine SP-C35 Transducer Protector is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is described as a "protective device for pressure monitors and to help prevent contamination of the fluid pathway in hemodialysis delivery systems." This function is related to the physical process of hemodialysis and protecting equipment, not to the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical components (plastic housing, hydrophobic filter, luer lock connectors) and their function in preventing fluid flow and contamination within the hemodialysis circuit. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
The device's function is purely mechanical and protective within a medical device system (hemodialysis machine).
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FIB
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.
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)
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 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 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.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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.
1
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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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
3
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
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (8/23)
న్న
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
4
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) | 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
7
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 Device
K072988 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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 Nipro Transducer Protector
TP-SURE 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. |
| Feature | Sterile
Non-pyrogenic
Single Use
Prescription Device | Sterile
Non-pyrogenic
Single Use
Prescription Device |
| Main Configuration | Filter Paper
Male Luer Lock Connector | Filter Paper
Male Luer Lock Connector |
8
| Item | | Proposed Device | Predicate Device
K072988 |
|-------------------------|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Cap | Cap |
| Physical
performance | Positive
pressure
Limitation
(mmHg) | 500 | 500 |
| | Negative
Pressure
Limitation
(mmHg) | -500 | -500 |
| Performance | | Conforms to
ISO 80369-7:2016 | Conforms to
ISO 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;
Pyrogenicity
Acute Toxicity;
Intracutaneous Reactivity;
Hemolysis Testing;
Implantation Testing;
Bacterial Endotoxin Testing |
| Sterilization | | Ebeam, SAL(10-6) | EO, SAL(10-6) |
| Labeling | | Direction for Use
Intended Use
Description
Warnings and Cautions | Direction for Use
Intended Use
Description
Warnings 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.