(274 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical performance of the tubing sets, with no mention of AI or ML capabilities.
No.
The device is a tubing set used to connect a patient to a hemodialyzer, which is the therapeutic device for hemodialysis. The tubing set itself facilitates the treatment but does not directly provide the therapy.
No
Explanation: The device description states that the product is "single use arterial and venous blood line (tubing) sets for use with polyethersulfone hollow-fiber hemodialyzers or other dialyzers that are indicated for hemodialysis treatment of acute and chronic renal failure. These tubing sets are intended for use as the extracorporeal blood circuit during hemodialysis and to connect a dialysis patient to a hemodialyzer." This describes a device used for treatment and connection, not for diagnosing a condition or disease.
No
The device description explicitly states it is comprised of physical components like tubing, connectors, and materials such as PVC, PP, PC, ABS, and PE. It also details performance studies related to structural integrity and physical properties, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Dimesol Tubing Sets for Hemodialysis are used to physically connect a patient to a hemodialysis machine and dialyzer. They are part of the extracorporeal blood circuit, facilitating the removal of waste products from the blood.
- Lack of Diagnostic Testing: The device itself does not perform any diagnostic tests on patient samples. It is a conduit for blood flow during a treatment procedure.
The provided information clearly describes a medical device used for a therapeutic procedure (hemodialysis), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Dimesol Tubing Sets for Hemodialysis are single-use sterile medical devices intended to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The compatibility of available configurations is the responsibility of the physician / clinician in charge.
Product codes (comma separated list FDA assigned to the subject device)
FJK, FKB
Device Description
The Dimesol blood tubing sets for hemodialysis are single use arterial and venous blood line (tubing) sets for use with polyethersulfone hollow-fiber hemodialyzers or other dialyzers that are indicated for hemodialysis treatment of acute and chronic renal failure. The major device components of these tubing sets are manufactured from medical-grade polyvinyl chloride (PVC), polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), and fire-retardant polyethylene (PE).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arterial / venous access
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals / hospital use
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)
The Dimesol (DORA) blood tubing sets for hemodialysis were tested for various biocompatibility factors and found to be within the accepted test parameters of ISO 10993. The Dimesol (DORA) blood tubing sets for hemodialysis were tested for various performance characteristics and found to be within the accepted test parameters of ISO 8638 and ISO 594-2. Testing indicated that the Dimesol Blood Tubing Sets for Hemodialysis are safe and effective for their intended use.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 30, 2018
Dimesol, Inc. % Courtney J. Miller Partner Frost Brown Todd LLC 10 West Broad Street, Suite 2300 Columbus. OH 43215
Re: K171952
Trade/Device Name: Dimesol Tubing Sets for Hemodialysis Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis System and Accessories Regulatory Class: II Product Code: FJK, FKB Dated: February 12, 2018 Received: February 13, 2018
Dear Courtney J. Miller:
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. 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.
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.
1
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 803); 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE STATEMENT
510(k) Number: K171952
FORM: FDA 3881
Device Name: Dimesol Tubing Sets for Hemodialysis
Indications for Use:
The Dimesol Tubing Sets for Hemodialysis are single-use sterile medical devices intended to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The compatibility of available configurations is the responsibility of the physician / clinician in charge.
X AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
K171952-REVISED 510(K) SUMMARY UNDER 21 CFR 807.92
This 510(k) summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content in this 510(k) summary has been provided in conformance with 21 CFR Part 807.92.
Submitter's Information A.
| (1) Name: | Frost Brown Todd LLC |
|---|---|
| (2) Address: | 10 West Broad St., Suite 2300, Columbus, OH 43215 USA |
| (3) Phone: | 614-559-7288 |
| (4) Fax: | 614-464-1737 |
| (5) Contact Person: | (Mr.) Courtney J. Miller, J.D., LL.M. |
| (6) Preparation Date: | June 27, 2017 |
On Behalf of Applicant Entity (owner of 510(k))
| (1) Applicant Name: | DIMESOL, INC. |
|---|---|
| (2) Applicant Address: | 509 Fishing Creek Rd., Lewisberry, PA 17339 USA |
| (3) Applicant Phone: | 717-938-8391 |
| (4) Applicant Fax: | 717-938-3957 |
Manufactured for Dimesol, Inc. by:
| (1) Manufacturer Name: | Bain Medical Equipment (Guangzhou) Co., Ltd. |
|---|---|
| (2) Manufacturer Address: | 10 Juncheng Road, Eastern Area, Guangzhou Economic & |
| Technological Development District, Guangzhou, China | |
| 510760 | |
| (3) Manufacturer Phone: | 0086-20-82265249 |
| (4) Manufacturer Fax: | 0086-20-32067500 |
B. Device Name
| (1) Trade Name: | Dimesol Tubing Sets for Hemodialysis |
|---|---|
| (2) Common Name: Blood Tubing (or Blood Line or Tubing) Sets for Hemodialysis | |
| (3) Classification: | Class II, per 21 CFR 876.5820 (Hemodialysis system and |
| accessories) | |
| (4) Product Code: | FJK / FKB: Gastroenterology/Urology |
| (5) Standard(s): | MDD 93/42/EEC; ISO 8638; ISO9001; ISO13485 |
4
K171952-REVISED 510(K) SUMMARY UNDER 21 CFR 807.92
C. Legally Marketed Predicate Device(s)
- Nipro Blood Tubing Set with Transducer Protector and Priming Set (K072024) - JMS Blood Tubing Sets (K032975)
D. Device Description
[0001] The Dimesol blood tubing sets for hemodialysis are single use arterial and venous blood line (tubing) sets for use with polyethersulfone hollow-fiber hemodialyzers or other dialyzers that are indicated for hemodialysis treatment of acute and chronic renal failure. TABLE 1. below, provides the basic product codes used for the Dimesol (blood tubing sets for hemodialysis. There are five (5) basic product codes that represent the various configurations (i.e., models) in which the device may be manufactured. TABLE 1 also provides the dimensions (in millimeters) for the pump segment and further identifies the hemodialysis system with which the devices are compatible. TABLE 2, below, provides the basic device components and their respective functions for both the arterial and venous lines.
TABLE 1. Product Codes and Specifications
| Product Code | Pump Seqment
(IDxODxLength in mm) | System/Device
Compatibilities |
|--------------|--------------------------------------|----------------------------------|
| EDIM-BL-001E | 8.00x12.00x350 | Fresenius 2008K |
| EDIM-BL-002E | 8.00x12.00x350 | Fresenius 2008K |
| EDIM-BL-003E | 8.00x12.00x350 | Fresenius 2008K |
| EDIM-BL-004E | 8.00x12.00x350 | Fresenius 2008K |
| EDIM-BL-005E | 8.00x12.00x350 | Fresenius 2008K |
TABLE 2. Basic Device Components and Functions (Dimesol: Arterial and Venous Lines)
| Component | Function | |
|---|---|---|
| 1 | Vented Dialyzer | |
| Connector Caps | Prevents contamination of blood path through Dialyzer Connector (Arterial/Venous Lines). | |
| 2 | Dialyzer Connectors | Connects the arterial and venous lines to the appropriate dialyzer blood port (Blue for venous line and Red for arterial line). |
| 3 | Blood (Drip) Chamber | |
| (with or w/o filter) | Provides an air space for monitoring pressures and trapping air bubbles. Venous blood chamber includes conical mesh filter to block clots and to trap foam, or air bubbles before entering patient | |
| 4 | Blood (Drip) Chamber Cover | Permits monitoring line and level adjustment line to be sited |
| 5 | Large On/Off Clamps | Typically located along the main blood lines for permitting occlusion of blood tubing set |
| 6 | Small On/Off Clamps | Typically located at all heparin lines, monitoring lines, and level |
5
K171952-REVISED 510(K) SUMMARY UNDER 21 CFR 807.92
| 7 | Luer Lock Connectors | adjusting lines for occlusion, if necessary. |
|---|---|---|
| 8 | Vented Caps for Luer Lock Connectors | Female luer lock connectors provide a connection site based on an internationally recognized standard within the entire blood tubing set. |
| 9 | Recirculation Luer Lock Connectors | Vented caps cover the luer lock connectors to prevent contamination. |
| 10 | Transducer Protectors (TP) | Recirculation connectors allow the connection of hemodialysis blood tubing for recirculation within the extracorporeal blood circuit. |
| 11 | Blood Injection Ports | Prevent blood contamination risk at pressure monitoring line to dialysis machine through the hydrophobic membrane |
| 12 | Patient Connectors (Self-Injection) | Provide access sites for blood sampling and/or medications administration (Red and Blue). |
| 13 | Heparin Infusion Line | International connection to vascular access devices (e.g., AV Fistula needle set) in the extracorporeal blood circuit. |
| 14 | Pump Segment and T-Connectors | Provides adequate anticoagulant for blood before entering dialyzer via a syringe pump. Normally includes a female luer lock connector, a small clamp, and small diameter tubing. |
| 15 | Tubing Segments | Delivery of blood at pre-determined pump rate. |
| 16 | Drainage Bag | Transports blood and fluid during hemodialysis; available in various sizes and lengths. |
| 17 | Negative Pressure Pillow | Collects priming saline waste. |
| 18 | IV | Collapses when predetermined negative pressures are detected. |
| 19 | Suspended Spike (Cap) | Infusion |
| Priming (plugged into saline bag) |
Dimesol tubing sets for hemodialysis are intended for use as the extracorporeal [0002] blood circuit during hemodialysis and to connect a dialysis patient to a hemodialyzer. These tubing sets are intended for single use only. The major device components of these tubing sets are manufactured from medical-grade polyvinyl chloride (PVC), polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), and fire-retardant polyethylene (PE).
E. Indications for Use
[0003] The Dimesol Tubing Sets for Hemodialysis are single-use sterile medical devices intended to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The compatibility of available configurations is the responsibility of the physician / clinician in charge.
6
K171952-REVISED 510(K) SUMMARY UNDER 21 CFR 807.92
F. Substantial Equivalence
[0004] The Dimesol (DORA) blood tubing sets (or simply "tubing sets") for hemodialysis are considered by the Submitter to be substantially equivalent in construction, design, materials, performance, and intended use to the JMS Blood Tubing Sets (K032975) and/or the Nipro Blood Tubing Set with Transducer Protector and Priming Set (K072024). All of these tubing sets are intended for use as a portion of the extracorporeal blood circuit during hemodialysis and to connect a dialysis patient to a hemodialyzer. The comparison to the JMS Blood Tubing Sets (K032975) is based primarily on structure, components, materials, and other features common to both the Dimesol blood tubing sets and JMS Blood Tubing Sets (K032975). However, the comparison to the Nipro Blood Tubing Set with Transducer Protector and Priming Set (K072024) is based on structure, components, and materials, as well as performance and biocompatibility.
[0005] As detailed in TABLE 3, below, the Dimesol (DORA) blood tubing sets for hemodialysis and the predicate JMS Blood Tubing Sets (K032975) and/or the Nipro Blood Tubing Set with Transducer Protector and Priming Set (K072024) have equivalent structural and materials characteristics. As detailed in TABLE 4, below, the Dimesol (DORA) blood tubing sets for hemodialysis and the predicate JMS Blood Tubing Sets (K032975) and/or the Nipro Blood Tubing Set with Transducer Protector and Priming Set (K072024) have equivalent general characteristics. As illustrated in TABLE 5, below, the Dimesol (DORA) blood tubing sets for hemodialysis were tested for various biocompatibility factors and found to be within the accepted test parameters of ISO 10993. The Nipro Blood Tubing Set with Transducer Protector and Priming Set (K072024) was also determined to meet the requirements of ISO 10993; thus, the two devices are substantially equivalent with regard to biocompatibility. As illustrated in TABLE 6, below, the Dimesol (DORA) blood tubing sets for hemodialysis were tested for various performance characteristics and found to be within the accepted test parameters of ISO 8638 and ISO 594-2. The Nipro Blood Tubing Set with Transducer Protector and Priming Set (K072024) was also determined to meet the requirements of ISO 8638 and ISO 594-2; thus, the two devices are substantially equivalent with regard to performance characteristics.
| | Component | Material | Blood
Contacting | Supplier | JMS
Blood Tubing Sets
(K032975) | Nipro
BloodTubing Sets
(K072024) |
|---|-----------------------------------|----------|---------------------|--------------|---------------------------------------|----------------------------------------|
| 1 | Vented Dialyzer
Connector Caps | PP | No | Bain Medical | component or
equivalent present | component or
equivalent present |
| 2 | Dialyzer
Connectors | PVC | Yes | Bain Medical | component or
equivalent present | component or
equivalent present |
TABLE 3. Substantial Equivalence Comparison Table: Components and Materials (A/V)
510(k) Premarket Notification for Dimesol, Inc. Blood Tubing Sets for Hemodialysis
7
K171952-REVISED 510(K) SUMMARY UNDER 21 CFR 807.92
| 3 | Blood (Drip)
Chamber
(with or w/o filter) | PVC | Yes | Bain Medical | component or equivalent present | component or equivalent present |
|----|-------------------------------------------------|-----|-----|--------------|---------------------------------|---------------------------------|
| 4 | Blood (Drip) Chamber Cover | PVC | Yes | Bain Medical | component or equivalent present | component or equivalent present |
| 5 | Large On/Off Clamps | PP | No | Bain Medical | component or equivalent present | component or equivalent present |
| 6 | Small On/Off Clamps | PP | No | Bain Medical | component or equivalent present | component or equivalent present |
| 7 | Luer Lock Connectors | PC | Yes | Bain Medical | component or equivalent present | component or equivalent present |
| 8 | Vented Caps for Luer Lock Connectors | PE | No | Bain Medical | component or equivalent present | component or equivalent present |
| 9 | Recirculation Luer Lock Connectors | PP | Yes | Bain Medical | component or equivalent present | component or equivalent present |
| 10 | Transducer Protectors (TP) | SBC | Yes | Bain Medical | component or equivalent present | component or equivalent present |
| 11 | Blood Injection Ports | PVC | Yes | Bain Medical | component or equivalent present | component or equivalent present |
| 12 | Patient Connectors (Self-Injection) | PC | Yes | Bain Medical | component or equivalent present | component or equivalent present |
| 13 | Heparin Infusion Line | PP | No | Bain Medical | component or equivalent present | component or equivalent present |
| 14 | Pump Segment and T-Connectors | PVC | Yes | Bain Medical | component or equivalent present | component or equivalent present |
| 15 | Tubing Segments | PVC | Yes | Bain Medical | component or equivalent present | component or equivalent present |
TABLE 4. Substantial Equivalence Comparison Table: General Factors (A/V)
| Factor | Dimesol (DORA) AVF Needle Set | JMS Blood Tubing Sets (K032975) | Nipro Blood Tubing Sets (K072024) | |
|---|---|---|---|---|
| 1 | Device Class | II | SE | SE |
| 2 | Product Code | FJK | SE | SE |
| 3 | Regulation No. | 21 CFR 876.5820 | SE | SE |
| 4 | intended use | hemodialysis | SE | SE |
| 5 | indications for use | acute and chronic | ||
| renal failure | SE | SE | ||
| 6 | instructions for use | - remove cap |
- insert needle into
patient's vein - connect with blood
tubing set | SE | SE |
| 7 | configuration of device | See Device Description | SE | SE |
| 8 | implantable device | non-implantable | SE | SE |
8
K171952-REVISED 510(K) SUMMARY UNDER 21 CFR 807.92
| 9 | target population | dialysis patients | SE | SE |
|---|---|---|---|---|
| 10 | anatomical sites | arterial / venous access | SE | SE |
| 11 | location of use | hospital use | SE | SE |
| 12 | energy used and/or | electric peristaltic | ||
| blood pump | SE | SE | ||
| 13 | human factors | used by medical | ||
| professionals | SE | SE | ||
| 14 | design factors | hemodialysis circuit | ||
| arterial and venous lines | SE | SE | ||
| 15 | performance | single use | SE | SE |
| 16 | materials | PVC, PP, PC, ABS, PE | PVC, PE, PP, ABS, | |
| PC | SE | |||
| 17 | biocompatibility | Compatible with ISO | ||
| 10993 series standards | Biocompatible | |||
| 10993 compatible | biocompatible | |||
| 18 | environmental | |||
| compatibility | disposable | SE | SE | |
| 19 | sterilization method | electron beam | ||
| (SAL 10-6) | SE | |||
| (SAL 10-6) | SE | |||
| (SAL 10-6) | ||||
| 20 | Non-pyrogenic | Non-pyrogenic | SE | SE |
TABLE 5. Biocompatibility Comparison with K072024
| Dimesol Blood Tubing Sets (K171952) | Predicate Device
(K072024) |
|-------------------------------------|-------------------------------|
| Cytoxicity | Biocompatible |
| Sensitization | Conforms to ISO
10993-1 |
| Intracutaneous Reactivation | |
| Acute systemic Toxicity | |
| Hemolysis | |
| Partial Thromboplastin Time | |
| Complement System | |
| In vitro Chromosomal Aberration | |
| Bacterial Reverse Mutation | |
| Mouse Bone Marrow Micronucleus | |
| Pyrogen | |
| Mechanical Hemolysis | |
9
K171952-REVISED 510(K) SUMMARY UNDER 21 CFR 807.92
TABLE 6. Performance Comparison with K072024
| Dimesol Blood Tubing Sets (K171952) | | Predicate Device
(K072024) |
|-------------------------------------|--------------------------------|--------------------------------|
| Specific Tests Performed | Conforms to ISO
8638: 2010 | Conforms to ISO
8638: 2010 |
| Structural Integrity | Conforms to ISO
594-2: 1998 | Conforms to ISO
594-2: 1998 |
| Connectors to Hemodialyzer | | |
| Needle Access Ports | | |
| Transducer Protectors | | |
| Tubing Compliance | | |
| Priming Volume | | |
| Pump Segment Performance | | |
| Conical Fitting | | |
| Tensile Strength | | |
| Simulated Operation | | |
| Repeated Closing | | |
| Endurance Testing | | |
G. Conclusion
[0006] The Dimesol blood tubing sets for hemodialysis are believed to be substantially equivalent in construction, design, materials, performance, and intended use to the JMS Blood Tubing Sets (K032975) and/or the Nipro Blood Tubing Set with Transducer Protector and Priming Set (K072024). All of these tubing sets are intended for use as a portion of the extracorporeal blood circuit during hemodialysis and to connect a dialysis patient to a hemodialyzer. In addition, testing of the Dimesol Blood Tubing Sets for Hemodialysis indicates that they are safe and effective for their intended use. The device labeling contains or includes a Package Insert, which includes indications for use, cautions and warnings, as well as the general operating instructions required for proper use of the device. This information promotes safe and effective use of the blood tubing set. Dimesol, Inc. believes that the information provided in this submission clearly describes the Dimesol Blood Tubing Sets for Hemodialysis and demonstrates that they are believed to be substantially equivalent to the aforementioned predicate device(s).