(72 days)
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Not Found
No
The summary describes a physical accessory for blood tubing and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is described as an "accessory" intended for "needle-free withdrawal of blood" in hemodialysis and other applications, and it is explicitly stated to be an "adjunct to blood tubing sets or venipuncture devices." Its function is for sampling blood, not for treating a condition or disease.
No
The device is described as an accessory for blood sampling and withdrawal during hemodialysis, not for diagnosing conditions.
No
The device description clearly states it is a "single use, sterile, non-pyrogenic device" and describes physical components like a "CLAVE Connector" and "Luer-locking adaptors," indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for facilitating blood sampling during hemodialysis and other chronic applications. It's a tool for collecting blood, not for testing it.
- Device Description: The description focuses on its function as an adjunct to blood tubing sets for needle-free blood withdrawal. It's a physical accessory for blood collection.
- Lack of Diagnostic Function: There is no mention of the device performing any analysis, testing, or diagnostic procedures on the blood sample itself. IVDs are designed to examine specimens (like blood) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies mentioned (hemolysis and microbial challenge) relate to the safety and integrity of the device for blood collection, not its diagnostic accuracy.
In summary, this device is a medical accessory for blood collection, not a diagnostic tool that analyzes the blood sample.
N/A
Intended Use / Indications for Use
The 'Blood Tubing Accessory with CLAVE Connector' is intended for use in hemodialysis and other chronic applications where blood sampling is required. Luer-locking adaptors allow secure, in-line placement between the blood tubing set and the catheter or venipuncture device. Use of a CLAVE connector allows the clinician needle-free blood withdrawal.
Product codes (comma separated list FDA assigned to the subject device)
78 FJK
Device Description
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Hemolysis study was conducted by independent laboratory and found that no significant hemolysis occurs with the use of the CLAVE Connector.
- Microbial challenge study showed that the CLAVE Connector maintained a sterile barrier for six days or 144 hours while administering 24 repeat activations per day. These results indicate that the CLAVE Connector, when using a standard disinfection protocol, did not increase infection rates under worst case clinical simulation.
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.
Not Found
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
ICCI Medical Inc.
Blood Tubing Accessory with CLAVE Connector
R983559
Page 1 of 2
510(k) Notification
Page 39 of 40
DEC 2 4 1998
10.0 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.
Name: Address: ICU Medical, Inc. 951 Calle Amanecer San Clemente, CA 92673
Contact Person: Phone Number: Fax Number:
Sheryl Sáenz (949)366-2183 (949)366-8368
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Applicant Information:
| Date Prepared: | October 7, 1998 |
|---|---|
| Name: | ICU Medical Inc. |
| Address: | 951 Calle Amanecer |
| San Clemente, CA 92673 |
| Contact Person: | Sheryl Sáenz |
|---|---|
| Phone Number: | (949) 366-2183 |
| Fax Number: | (949) 366-8368 |
Device Information:
| Trade Name: | Blood Tubing Accessory with CLAVE Connector |
|---|---|
| Common Name: | Blood Access Accessory |
| Classification Name: | Blood Access Device / Accessories |
Equivalent Device:
MEDISYSTEMS ReadySet® Hemodialysis Blood Tubing Set, needle injection sites
Device Description:
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
1
510(k) Notification Page 40 of 40
Blood Tubing Accessory with CLAVE Connector
Intended Use:
The 'Blood Tubing Accessory with CLAVE Connector' is intended for use in hemodialysis and other chronic applications where blood sampling is required. Luer-locking adaptors allow secure, in-line placement between the blood tubing set and the catheter or venipuncture device. Use of a CLAVE connector allows the clinician needle-free blood withdrawal.
Comparison To Predicate Device:
| Characteristic | ICU MEDICAL'S BLOOD TUBING
ACCESSORY WITH CLAVE®
CONNECTOR | Injection sites included on MEDISYSTEMS
READYSET HEMODIALYSIS BLOOD
TUBING SET |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Product
Labeling | Sterile Use, Non-Pyrogenic, Sterile fluid
pathway in unopened, undamaged package.
Directions for use on labeling. | Sterile Use, Directions for use on labeling |
| Intended Use | Needle-free port to access any vein, or artery. | Needle injection sites on arterial and venous tubing
sides for blood aspiration from tubing. |
| Design | One-piece connector activated by luer
connection to allow blood withdrawal. Tubing
and connectors are straight-line to minimize
turbulence. | Pierceable septum secured in durable housing
which is bonded to blood tubing set. |
| Materials | Y-Connector-Polyester
Male Luer: Polypropylene
Female Luer: Polyester
Blood Tubing Extension: Polyvinylchloride
CLAVE Connector: Polycarbonate,
Polyester, Silicone, Fluorosilicone,
Polypropylene, Polyethylene
Packaging - Medical packaging grade fiber-
free peelable paper lidding and pouching
material. | Septum -Thermoplastic elastomer
Housing - Polycarbonate
Blood Tubing - Polyvinylchloride |
Conclusions of nonclinical tests:
- . Hemolysis study was conducted by independent laboratory and found that no significant hemolysis occurs with the use of the CLAVE Connector.
- . Microbial challenge study showed that the CLAVE Connector maintained a sterile barrier for six days or 144 hours while administering 24 repeat activations per day. These results indicate that the CLAVE Connector, when using a standard disinfection protocol, did not increase infection rates under worst case clinical simulation
simulation.
Sheryl Sáenz
Sheryl Sáenz
Regulatory Affairs Specialist ICU Medical, Inc.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K983559
Blood Tubing Accessory with CLAVE® Connector Dated: October 7, 1998 Received: October 13, 1998 Regulatory Class: II 21 CFR 876.5540/Procode: 78 FJK
Dear Ms. Saenz:
Ms. Sheryl Saenz
ICU Medical, Inc.
951 Calle Amanecer
Regulatory Affairs Specialist
San Clemente, CA 92673
DEC 24 1998
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/odrb/dsmaldsmamain.html".
Sincerely your
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Device Name: Blood Tubing Accessory with CLAVE Connector
INDICATIONS FOR USE
The 'Blood Tubing Accessory with CLAVE Connector' is intended for use in hemodialysis and other chronic applications where blood sampling is required. Luer-locking adaptors allow secure, in-line placement between the blood tubing set and the catheter or venipuncture device. Use of a CLAVE Connector allows the clinician needle-free blood withdrawal.
(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 |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
:
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, | |
| and Radiological Devices | |
| 510(k) Number | K983559 |
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: 上 i
Concurrence of CDRH, Office of Device Evaluation (ODE)