SPECATH® Central Venous Catheters are intended for the purpose of providing short term access (less than 30 days) to the vascular system for the infusion of fluids, monitoring of pressures, and/or sampling of blood.

Device Description

SPECATH® catheters are polyurethane, radiopaque single or multiple (up to 4) lumen catheters. The size of catheters are from 4 French through 12 French and lengths 10 cm through 30 cm. Each lumen extends from the vicinity of the distal tip to the main (bifurcation or junction) hub, where it branches into dedicated extension lines. The extension line hubs are labeled to provide positive identification of the lumen size and location. The catheter body has depth markings, measured in cm from the catheter tips. The extension line marked "distal" is used for device placement using a guide wire and then to infuse fluids. The distal tip is soft to minimize patient trauma during insertion. The device is radiopaque to allow verification of location in the patient. Central venous catheters are inserted into a large vein and threaded into the central venous system. To reduce the chance of complications, the central venous catheter tip should be placed in the superior vena cava above its junction with the right atrium with the distal catheter parallel to the vessel wall. For reference. the distal tip should be positioned at a level above either the azvaos vein or the carina of the trachea whichever is better visualized. The accessories described below will be included in the SPECATH® Central Venous Catheter Kits. Guidewires: The quidewire is used for quiding the catheter through the venous a. system to the desired catheter placement location. According to the different sizes of the catheters, varying size quidewire will be included in the kit: Diameters are 0.018", 0.035"; Lengths are 450mm (45cm), 500 mm (50cm), 700mm (70cm), 1500mm (150 cm), b. Vessel Dialators: Dialators are used to enlarge the introducer path of the catheter. According to the size of the catheter, there will be a corresponding dialator with different size and effective lengths. C. Introducer: The introducer is used for entrance and tunneling into the skin and vascular system for the purpose of catheter placement. According to the size of the catheter, the following introducers will be included: 18 Ga, 70 mm; 19 Ga, 45 mm; 20 Ga, 45 mm. ರ. Syringe: A 5 ml. Svringe manufactured by Becton Dickinson and used to infuse fluids into the catheter will be included in the kit. Injection Caps: The injection cap is connected to the female luer hubs of the e. extension tubes.

AI/ML Overview

The provided text describes a 510(k) submission for the SPECATH® Central Venous Catheter Kits. This is a premarket notification to demonstrate that a device is substantially equivalent to a legally marketed predicate device, rather than a study evaluating the performance of a device against specific acceptance criteria in a clinical or standalone setting.

Therefore, many of the requested details, such as acceptance criteria, reported device performance, sample size for test sets, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and details about training sets, are not applicable or available in this type of submission.

Instead, the submission focuses on non-clinical tests to support the substantial equivalence claim.

Here's a breakdown of the information provided that relates to your request:

1. A table of acceptance criteria and the reported device performance

The document lists various non-clinical tests performed, implying that the device met certain internal specifications or industry standards for these tests to claim substantial equivalence. However, the specific acceptance criteria (e.g., "flow rate must be > X ml/min") and the reported device performance results (e.g., "flow rate was Y ml/min") are not provided in this summary.

Acceptance Criteria (Implied)	Reported Device Performance
Surface acceptability	(Not specified)
Size conformance	(Not specified)
Distance Markings accuracy	(Not specified)
Lumen Markings clarity	(Not specified)
Primary Volume Test results	(Not specified)
Break Force strength	(Not specified)
Flow Rate conformity	(Not specified)
Burst Pressure Test results	(Not specified)
Leakage absence	(Not specified)
Tensile Strength Test results	(Not specified)
Radio-detectability	(Not specified)
Hub Liquid Leakage absence	(Not specified)
Hub Air Leakage absence	(Not specified)
Hub Separation Force strength	(Not specified)
Hub Stress Cracking resistance	(Not specified)
Label Information accuracy	(Not specified)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified. The document only mentions "Testing to Support Substantial Equivalence included" a list of non-clinical tests. These are typically bench tests or in-vitro tests, so the concept of "test set" in the context of patient data is not applicable here.
Data Provenance: Not applicable. These are non-clinical, bench-top tests, not human data. The manufacturing company is Special Medical Co. Ltd. from Guangdong, China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth from experts is relevant for clinical studies or studies involving human judgment (e.g., image interpretation). These are non-clinical, quantifiable tests where "ground truth" would be established by the physical properties of the device and testing equipment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this refers to adjudication for human-interpreted data or clinical outcomes.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a non-clinical submission for a medical device (catheter kit), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as this is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" is implied to be the physical and chemical specifications of the device material and design, as measured and verified against established engineering and safety standards.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical device.

9. How the ground truth for the training set was established

Not applicable for the same reason as above.

Summary

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JAN 0 7 2003

Attachment #6

510(K) SUMMARY

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.

The assigned 510(k) number is: 1021130

1. Submitter's Identification:

Special Medical Co. Ltd. No. 3 Industrial Building, National Hi-Tech Development Zone GangKou Road Guangdong 528041, China

Contact: Dr. Yung-jin Lee

Date Summary Prepared:

April 5, 2002

2. Name of the Device:

SPECATH® Central Venous Catheter Kits

3. Predicate Device Information:

1. K#963257, Peripherally Inserted Medline Catheter, Arrow International, Inc.
1. K#900263 Anti-Microbial Multi-Lumen Central Venous Catheter, Arrow International, Inc.
1. K#971085, Soft Tip Multi-Lumen Central Venous Catheter, B. Braun Medical, Inc.

4. Device Description:

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The distal tip is soft to minimize patient trauma during insertion. The device is radiopaque to allow verification of location in the patient.

Central venous catheters are inserted into a large vein and threaded into the central venous system. To reduce the chance of complications, the central venous catheter tip should be placed in the superior vena cava above its junction with the right atrium with the distal catheter parallel to the vessel wall. For reference. the distal tip should be positioned at a level above either the azvaos vein or the carina of the trachea whichever is better visualized.

The accessories described below will be included in the SPECATH® Central Venous Catheter Kits.

Guidewires: The quidewire is used for quiding the catheter through the venous a. system to the desired catheter placement location. According to the different sizes of the catheters, varying size quidewire will be included in the kit: Diameters are 0.018", 0.035"; Lengths are 450mm (45cm), 500 mm (50cm), 700mm (70cm), 1500mm (150 cm),
b. Vessel Dialators: Dialators are used to enlarge the introducer path of the catheter. According to the size of the catheter, there will be a corresponding dialator with different size and effective lengths.
C. Introducer: The introducer is used for entrance and tunneling into the skin and vascular system for the purpose of catheter placement. According to the size of the catheter, the following introducers will be included: 18 Ga, 70 mm; 19 Ga, 45 mm; 20 Ga, 45 mm.
ರ. Syringe: A 5 ml. Svringe manufactured by Becton Dickinson and used to infuse fluids into the catheter will be included in the kit.
Injection Caps: The injection cap is connected to the female luer hubs of the e. extension tubes.

5. Intended Use:

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6. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

KO21130

Testing to Support Substantial Equivalence included:

Surface .
Size .
Distance Markings ●
. Lumen Markings
Primary Volume Test ●
. Break Force
. Flow Rate
Burst Pressure Test .
Leakage ●
Tensile Strength Test ●
Radio-detectability ●
. Hub Liquid Leakage
Hub Air Leakage ◆
Hub Separation Force
Hub Stress Cracking
Label Information .

7. Discussion of Clinical Tests Performed:

Not applicable as there are no new indications for use which must be supported by clinical data.

8. Conclusions:

The subject device, SPECATH® Central Venous Catheter Kits, has the same intended use and characteristics as a combination of the predicate devices. Moreover, bench testing contained in our submission and non-clinical testing supplied demonstrates that there are no difference in their technological characteristics, thereby not raising any new question of safety and effectiveness. Thus, the SPECATH® Central Venous Catheter Kits are substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

JAN 0 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Special Medical Company Limited C/O Ms. Susan D. Goldstein-Falk MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K021130

Trade/Device Name: SPECATH® Central Venous Catheter Kits Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: November 22, 2002 Received: November 26, 2002

Dear Ms. Falk:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Fecleral Register.

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Page 2 - Ms. Falk

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy Ulatowski

Timot latowski Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment #5

Page 1 of of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name SPECATH® Central Venous Catheter Kits

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	Y	Over-The-Counter Use
(Per 21 CFR 801.109)	OR	(Optional Format 1-2-96)

VAN NARAYANWA for PXC

(Division Sign-Off)

Division of Anesthesiology General Hospital
strieslology, General Hospital, Infection Control, Dental Devices

510(k) Number. K021130

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).