(58 days)
Not Found
No
The description focuses on mechanical design modifications and fluid flow control, with no mention of AI or ML.
No.
The device is a flow control and conduit device for IV fluids, and its function is to deliver or manage fluids, not to directly treat a condition or restore function.
No
The device is described as a flow control and conduit device for I.V. fluid delivery, allowing for gravity feed, sampling, and injection, but not for diagnosing medical conditions.
No
The device description clearly outlines physical components such as a body, handles, elastomer, rotor, check valve, port covers, and colored buttons, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "I.V fluids delivery to the patient's vascular system." This involves delivering substances into the body, not testing samples from the body.
- Device Description: The description details components related to fluid flow control and delivery (ports, handles, valves, rotor). There is no mention of components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.
The device is a medical device used for fluid management during intravenous therapy, which is a different category than in vitro diagnostics.
N/A
Intended Use / Indications for Use
New modified SafePort Manifold or Stopcock is a one or multiple ports product, which is indicated to serve as a flow control and a conduit device for I.V fluid delivery to the patient's vascular system. The product is intended for delivering of I.V. drugs or fluids, allowing gravity feed, sampling bolus injection and elimination or reflux of fluid during operation.
Product codes (comma separated list FDA assigned to the subject device)
FMG
Device Description
Modified SafePort Manifold (or Stopcock) is a redesign of Induction & Sampling Manifold (or Stopcock). It has the same appearance and intended use while several design modifications were introduced in order to contribute to the device's convenience of use and robustness. The device will be available in two (2) versions swabable or standard ports configurations. The first version, standard port configuration is similar to the predicate device but with more robust design. The second version, besides of the design changes have an additional feature. The feature is the swabable valves which can be incorporated into the female side ports and function as a closed luer activate valve. The swabable valve enables the female port (luer) to be closed when it is not in use and saves the need to close it with a cap in order to avoid leakage and/ or port's contamination and serves as a needleless injection site integrated in the stopcock. Devices having the swabable valves have been demonstrated in a 510(k) submission for Elcam's Closed Stopcock.
SafePort Manifold or Stopcock is composed of the following components:
- -One piece injected body having a side female ports. (with or without swabable valves according to the end user request)
- Handles assembled into the female side ports. ー
- -Elastomer placed between each handle and side female port body, which is placed to function as a pressure activated valve activated valve.
- Rotor assembled to the male port (connected toward the patient ) for . " connection locking.
- -Check valve assembled to the male port which is connected toward the patient in order to enable connection locking. (this part will not be included, unless otherwise requested by the end user)
- Port covers and colored buttons. (if requested by an end user) -
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)
Testing relating functionality of the SafePort Manifold's different variation has been conducted in a series of non-clinical tests presented in Section 7 of the submission. It was shown that the modified device is as safe and as effective as its predicates.
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
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image shows a logo for Elcam Medical. The logo is black and white and features the words "Elcam Medical" stacked on top of each other. To the right of the text is a stylized image that appears to be a medical device or component. The logo is simple and modern, and it is likely used to represent the company's brand.
Special 510(k) for SafePort Manifold™ (or Stopcock)
Applicant: Elcam Medical ACAL
KIIIOIb
510(k) SUMMARY [As Required by 21 CFR 807.92(c)]
JUN - 9 2011
Date Prepared: April 3, 2011
Applicant Name: Elcam Medical ACAL
Kibbutz BarAm, Merom Ha Galil 13860, Israel
Contact Person Name: Ms. Natasha Evronyan – R.A. and Q.A. Engineer
Telephone: 972-4-6988821
Fax: 972-4-6980777
E-mail: Natasha.ev@elcam.co.il
Elcam Medical's U.S. Agent: Mr. Lloyd Fishman – President
Elcam Medical, Inc.
2 University Plaza, Suite 620,
Hackensack, NJ 07601, USA
Phone: 201- 457- 1120
Fax: 201- 457- 1125
E-mail: Lloyd.fishman@elcam-medical.com
Predicate Device:
Elcam's Induction & Sampling Manifold (or Stopcock) cleared under 510(k) # K032393.
Device Name
Common/ Usual Name: SafePort Manifold™ (or Stopcock)
Proprietary/ Trade Name: SafePort Manifold™ (or Stopcock)
April 3, 2011
- Confidential-
nave 43 of 45
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Image /page/1/Picture/0 description: The image shows a logo for Elcam Medical. The logo consists of a black square with the words "Elcam" and "Medical" stacked on top of each other in white font. The text is positioned in the lower-left corner of the square. The logo is simple and modern, with a focus on the company name.
Classification: Elcam's SafePort Manifold has been classified as Class II device under the following classification names:
Classification Name | Product Code | 21 CFR Ref. | Panel |
---|---|---|---|
Intravascular Administration | |||
I.V. Set | FMG | 880.5440 | General Hospitals |
Device Description:
Modified SafePort Manifold (or Stopcock) is a redesign of Induction & Sampling Manifold (or Stopcock). It has the same appearance and intended use while several design modifications were introduced in order to contribute to the device's convenience of use and robustness. The device will be available in two (2) versions swabable or standard ports configurations. The first version, standard port configuration is similar to the predicate device but with more robust design. The second version, besides of the design changes have an additional feature. The feature is the swabable valves which can be incorporated into the female side ports and function as a closed luer activate valve. The swabable valve enables the female port (luer) to be closed when it is not in use and saves the need to close it with a cap in order to avoid leakage and/ or port's contamination and serves as a needleless injection site integrated in the stopcock. Devices having the swabable valves have been demonstrated in a 510(k) submission for Elcam's Closed Stopcock.
SafePort Manifold or Stopcock is composed of the following components:
- -One piece injected body having a side female ports. (with or without swabable valves according to the end user request)
- Handles assembled into the female side ports. ー
- -Elastomer placed between each handle and side female port body, which is placed to function as a pressure activated valve activated valve.
- Rotor assembled to the male port (connected toward the patient ) for . " connection locking.
- -Check valve assembled to the male port which is connected toward the patient in order to enable connection locking. (this part will not be included, unless otherwise requested by the end user)
- Port covers and colored buttons. (if requested by an end user) -
April 3, 2011
- Confidential-
2
新闻 - 文章
Image /page/2/Picture/1 description: The image shows a logo for Elcam Medical. The logo is a black square with the words "Elcam Medical" in white text. The word "Elcam" is on top of the word "Medical". The logo is simple and modern.
Indication for Use:
New modified SafePort Manifold or Stopcock is a one or multiple ports product, which is indicated to serve as a flow control and a conduit device for I.V fluid delivery to the patient's vascular system. The product is intended for delivering of I.V. drugs or fluids, allowing gravity feed, sampling bolus injection and elimination or reflux of fluid during operation.
Technological Characterizes and Substantial Equivalence:
Elcam's modified SafePort Manifold (or Stopcock )without luer activated/ swabable valves has the same indication for use, principle of operation, shape, sterilization method and shelf life as its main predicate Induction and Sampling Manifold (or Stopcock).
The modified SafePort Manifold with luer activated/ swabable valves, a new feature cleared in the 510 (k) submissions for Closed Stopcock (MRVLS) is also the same as the predicate from the aspects mentioned above except for principles of operation requiring the specific treatment for the valves. The same principles have been introduced in the 510(k) submission for Closed Stopcocks (MRVLS).
There were no questions regarding the new product safety and effectiveness that were raised due to the non- identical technological characteristics.
Performance Data:
Testing relating functionality of the SafePort Manifold's different variation has been conducted in a series of non-clinical tests presented in Section 7 of the submission. It was shown that the modified device is as safe and as effective as its predicates.
Clinical Data:
No clinical trials have been preformed for the modified SafePort Manifold.
Conclusion:
lt was demonstrated that the modified SafePort Manifold is substantially equivalent to its predicate, Induction & Sampling Manifold (or Stopcock), and do not raise any questions of safety and effectiveness.
- Confidential-
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of an abstract symbol that resembles a person embracing an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Natasha Evronyan O.A and R.A. Engineer Elcam Medical A.C.A.L. Kibbutz Bar-Am MP Merom HaGalil, Israel 13860
JUN - 9 2011
Re: K111016
Trade/Device Name: Safeport ManifoldTM Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: May 24, 2011 Received: May 31, 2011
Dear Ms. Evronyan:
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.
4
Page 2- Ms. Evronyan
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
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-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. 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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Image /page/5/Picture/0 description: The image shows the logo for Elcam Medical. The logo consists of the letters 'lc' stacked vertically, with the word 'Elcam' above the word 'Medical' to the left of the letters. A solid black circle is positioned above the 'c' in 'lc'.
Indication for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Safeport Manifold
Indications for Use: Safeport Manifold is indicated to serve as a flow control and a conduit device for I.V fluids delivery to the patient's vascular system. The product is intended for delivering 1.V drugs or fluids, allowing gravity feed, sampling, bolus injection and elimination of reflux of fluids during operation
Prescription Use _ X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nuhul the
Acting for
Russell Chapman
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K111016
Elcam Medical
Tel: 972-4-698-8120/1/2, Fax: 972-4-698-0777 sales@elcam.co.il