(15 days)
K 982805, K 013073
Not Found
No
The 510(k) summary describes a standard intravascular catheter and its performance testing based on established ISO standards and USP guidelines. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes.
The device description explicitly states that the intravascular catheter is designed to be used for "diagnostic and/or therapeutic purpose."
No
The text explicitly states that the device is for "introduction or withdrawal of liquids into or from the peripheral vascular system" and "infusion of I.V. Solutions" and "Intermittent intravenous Drug administration", which are therapeutic actions, not diagnostic. Although the ISO definition mentions "diagnostic and/or therapeutic purpose", the specific intended uses for this particular device only describe therapeutic applications.
No
The device description clearly states it is a "short flexible plastic tube" and an "over-needle-peripheral catheter," which are physical hardware components. The performance studies also focus on physical and material properties.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for introducing fluids or medicament into peripheral veins and/or withdrawing blood samples. This is a direct interaction with the patient's body for therapeutic or diagnostic purposes in vivo.
- Device Description: The description reinforces that it's a tubular device inserted into the cardiovascular system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body in vitro to provide information for diagnostic, monitoring, or compatibility purposes. The performance studies focus on the physical properties, biocompatibility, and sterility of the catheter itself, not on the analysis of biological samples.
Therefore, this device is a medical device used for accessing the vascular system, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
INTENDED USE: Intravascular catheter is a medical device intended to be used to introduce fluids or medicament through the peripheral veins and / or withdrawal of blood samples.
Intravascular catheter comprises of a short flexible plastic tube (the Catheter) which is inserted into a vein over a hollow introducer needle, after which the needle is withdrawn and discarded.
The intravascular catheter is used in aseptic environment.
Federal law (USA) restricts this device to sale by or on the order of a physician.
INDICATIONS FOR USE: - Infusion of I.V. Solutions.
- Intermittent intravenous Drug administration.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
As per ISO 10555-1, the generic definition of an intravascular catheter is - Intravascular catheter is a tubular device, single or multi lumen, designed to be partially or totally inserted into the cardiovascular system for diagnostic and/or therapeutic purpose
The device under this submission is an over-needle-peripheral catheter.
Over - the - needle peripheral intravascular catheters are intended for accessing the peripheral vascular system, supplied in the sterile condition and intended for single use. These catheters are designed for the introduction or withdrawal of liquids into or from the peripheral vascular system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician; aseptic environment
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)
In-vitro performance testing of the Medican Alpha included Design Qualification, visual analysis and Physical Analysis as per ISO 10555-1 & ISO 10555-5 [Sterile, Single-use intravascular catheter - (1) General requirements and (5) Over Needle Peripheral Catheter]. The Medican Alpha has also been tested for Physicochemical testing like Non volatile residue, Heavy metals, Residue on ignition, Buffering capacity, Bacterial Endotoxin tests and Sterility test as per USP-29.
The results have confirmed that Medican Alpha meets the requirement for all general and specific requirements of ISO 10555-1 & ISO 10555-5; and also passes the Physiochemical, Bacterial Endotoxin and Sterility tests as per USP-29
The Biocompatibility of the Medican Alpha has been verified in accordance with ISO 10993-1:1997 (Biological Evaluation of Medical Devices). Test results confirmed Biocompatibility of the catheter when tested as an External Communicating, Circulating Blood contact, and prolonged Exposure (>24 hrs to 30 days) device.
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.
K 982805, K 013073
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
§ 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).
0
E063469
Page No.: 059
1 of 2
510 (K) Summary of Safety and Effectiveness for 'Medican Alpha'
:
| DATE: | October 27, 2006 |
|---|---|
| SUBMITTER: | EASTERN MEDIKIT LIMITED, |
| 196, Udyog Vihar, Phase-1, | |
| Gurgaon-122 016 (Haryana) | |
| CONTACT PERSON: | RAJEEV ASRI |
| PHONE NUMBER: | + 91-124-4001831 (extn. 259) |
| FAX NUMBER: | + 91-124-4001835 |
| E-MAIL: | rajeevasri@medikit.com |
| TRADE NAME: | Medican Alpha |
| COMMON OR USUAL NAME: | CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT TERM (LESS THAN 30 DAYS). |
| [Various Sizes of IV Catheters / Cannulae] | |
| CLASSIFICATION NAME: | Catheter, intravascular, therapeutic, short term less than 30 days |
| DEVICE CLASSIFICATION: | Class II, 21 CFR 880,5200: Intravascular Catheter |
| PREDICATE DEVICE(S): | B. Braun Medical Inc. - 1-Introcan W [K 982805] |
| Becton Dickinson - BD Insyte ™ [K 013073] | |
| DESCRIPTION: | As per ISO 10555-1, the generic definition of an intravascular catheter is - Intravascular catheter is a tubular device, single or multi lumen, designed to be partially or totally inserted into the cardiovascular system for diagnostic and/or therapeutic purpose |
| The device under this submission is an over-needle-peripheral catheter. | |
| Over - the - needle peripheral intravascular catheters are intended for accessing the peripheral vascular system, supplied in the sterile condition and intended for single use. These catheters are designed for the introduction or withdrawal of liquids into or from the peripheral vascular system. | |
| INTENDED USE: | Intravascular catheter is a medical device intended to be used to introduce fluids or medicament through the peripheral veins and / or withdrawal of blood samples. |
| Intravascular catheter comprises of a short flexible plastic tube (the Catheter) which is inserted into a vein over a hollow introducer needle, after which the needle is withdrawn and discarded. | |
| The intravascular catheter is used in aseptic environment. | |
| Federal law (USA) restricts this device to sale by or on the order of a physician. | |
| INDICATIONS FOR USE: | - Infusion of I.V. Solutions. |
| - Intermittent intravenous Drug administration. |
DEC - 1 2006に、その他、その他、その他、その他、その他、その他、その他、一般的な人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の
ないと、その他の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の
1
Page No.: 060
K0634168
2 of 2
SUMMARY OF NON-CLINICAL PERFORMANCES AND CONCLUSIONS:
In-vitro performance testing of the Medican Alpha included Design Qualification, visual analysis and Physical Analysis as per ISO 10555-1 & ISO 10555-5 [Sterile, Single-use intravascular catheter - (1) General requirements and (5) Over Needle Peripheral Catheter]. The Medican Alpha has also been tested for Physicochemical testing like Non volatile residue, Heavy metals, Residue on ignition, Buffering capacity, Bacterial Endotoxin tests and Sterility test as per USP-29.
The results have confirmed that Medican Alpha meets the requirement for all general and specific requirements of ISO 10555-1 & ISO 10555-5; and also passes the Physiochemical, Bacterial Endotoxin and Sterility tests as per USP-29
The Biocompatibility of the Medican Alpha has been verified in accordance with ISO 10993-1:1997 (Biological Evaluation of Medical Devices). Test results confirmed Biocompatibility of the catheter when tested as an External Communicating, Circulating Blood contact, and prolonged Exposure (>24 hrs to 30 days) device.
In comparative study of Medican Alpha IV Catheter with Becton Dickinson catheter premarket notification, BD Insyte, it is found that The Medican Alpha IV Catheter is similar in respect of material, design and intended use with Becton Dickinson catheter. "BD Insyte ™". The only two major differences are ") presence of luer cap in Medikit Brand catheter and 2) that of packaging (blister) material. A luer cap is an additional feature in Medican Alpha and does not alter any functional aspect of the device. The packaging material does not affect the functional use of product as both provide a sterile package till the shelf life period. Therefore, Medican Alpha may be considered as substantially equivalent to "BD Insyte TM".
In comparative study of Medican Alpha IV Catheter with B Braun catheter premarket notification, 1-Introcan W, it is observed that The Medican Alpha IV Catheter is similar in respect of material, design and intended use with B Braun catheter, 1-Introcan W. The two major differences are 1) the safety feature of the predicate device that is not present in the Medikit brand Medical Alpha and 2) presence of luer cap in Medikit Brand catheter; this is an additional feature of Medican Alpha. Therefore, Medican Alpha may be considered as substantially equivalent to B Braun catheter, 1-Introcan W, except for the Safety features provided in B Braun 1-Introcan W.
SUBSTANTIAL EQUIVALENCE:
4
2
Public Health Service
Image /page/2/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC = 1 2006
Eastern Medikit Limited C/O Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
Re: K063469
Trade/Device Name: Medican Alpha Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: November 15, 2006 Received: November 16, 2006
Dear Mr. Devine:
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 vour 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.
3
Page 2 - Mr. Devine
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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-fice number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Kunnes
A Chiu Lin. Ph.D. 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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Page No.: 061
Indications for Use
510(k) Number (if known): Not yet assigned
Device Name: Medican Alpha
Indications for Use:
- Infusion of I.V. Solutions.
- Intermittent intravenous Drug administration.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
and the country of the states
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
lee R.ADW 12/1/20
Con of Anesthesiolo
K0634169