(168 days)
No
The summary describes a physical medical device (vascular port and access system) and its performance characteristics. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is designed for the delivery of medications, nutritional supplementation, fluids, blood, and blood products, and the sampling of blood, which falls under therapeutic interventions. It is also indicated for power injection of contrast media, which is often part of a diagnostic procedure aiding in patient treatment.
No.
The device is described as a port access system and infusion set for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and the sampling of blood, and for power injection of contrast media. Its primary function is therapeutic delivery and access, not diagnostic assessment or interpretation of medical conditions.
No
The device description clearly details physical components like a Titanium port, silicone rubber septum, catheters, and a needle set, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. These tests are performed outside the body.
- Device Function: The description clearly states the device is a "Port Access System" and "infusion set" used for "repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and the sampling of blood." It is also used for "power injection of contrast media."
- Intended Use: The intended use is for accessing the body's vascular system for therapeutic and diagnostic purposes (sampling blood), but the device itself is not performing a diagnostic test on the sample in vitro. It's a tool for accessing the body to obtain the sample or deliver substances.
The device is an implanted medical device used for accessing the body's internal systems, not for performing tests on samples outside the body.
N/A
Intended Use / Indications for Use
The Vortex® CT Port Access System is indicated for any patient requiring repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and the sampling of blood.
When used with non Y site LifeGuard Safety infusion sets in 20 Ga or 19Ga sizes, the Vortex® CT Port Access System is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec.
Product codes (comma separated list FDA assigned to the subject device)
LJT, FPA
Device Description
The Vortex® CT Port is a Titanium port with a self sealing silicone rubber septum designed to maintain integrity after punctures with a non-coring needle. The port has a hollow area, or reservoir, under the septum through which fluid passes during infusion or aspiration.
The Vortex design features a proprietary reservoir with rounded walls giving it a toroidal shape. The outlet stem is located tangential to the reservoir wall allows fluid to pass between the reservoir and the catheter.
The Vortex® Port Access systems offer models with single lumen 7.5 French to 9.6 French catheters made from either polyurethane or silicone. The catheters all contain radiopacifiers, and depth markings.
A more detailed description of the components of the Vortex® Port Access System is as follows;
Port Body: The body of the port is crafted of Titanium. Suture sites are incorporated into the port base to facilitate anchoring to the underlying tissue.
Reservoir: The reservoir is the hollow area under the septum, into which the non-coring needle is inserted for administration or withdrawal of fluids. The toroidal wall shape and a tangential outlet stem interface to facilitate flushing of the system.
Outlet stem: The port outlet stem is made from Titanium. Connection to the stem is accomplished through barbed connectors. The stem is located tangentially to the reservoir. The catheter is placed over stem, and locked into place. This creates a fluid connection with the reservoir.
Port septum: The port septum is the component through which the non-coring needle is inserted. The septum is self sealing, designed to maintain integrity after repeated punctures and is constructed from silicone (NuSil MED 4850).
Catheter: The available catheters are 7.5 or 9.6 French made from silicone (NuSil MED 4765) impregnated with a 15% BaSO4 in the cannula. The catheters include a blue stripe and tip loaded 25% BaSO4 for improved radiopacity. All catheters have depth markings to 65 cm to allow for precise placement.
Locking Mechanism: The cylindrical locking mechanism is made from silicone. The lock is advanced over the catheter until it positively locks onto the port stem, thereby compressing the catheter onto the stem and sealing the system.
Implantation: The Vortex® Port Access System is totally implanted in the body. The catheter is placed by percutaneous puncture technique with the distal tip at the juncture of the superior vena cava and right atrium via the jugular or subclavian vein. A subcutaneous pocket is prepared for placement of the port. The appropriate catheter length is determined, and the excess is trimmed by cutting straight across the proximal end. The catheter is marked up to 65 cm to allow more precise placement in the desired location. The catheter is attached to the port using the locking mechanism. The port body is secured by suturing through the base to the underlying fascia prior to wound closure.
The Vortex® port has significant physical and performance characteristics that make it an ideal candidate for indication for power injection. These characteristics include; All Titanium construction for maximum strength, barbed outlet stems for ease and simplicity of catheter connection, and maximum connection strength, combination locking mechanism / strain relief for simple locking, and maximum catheter protection.
The LifeGuard safety infusion set is a port access needle set with an integrated proprietary safety feature to prevent re-bound injury. The safety infusion set includes a huber needle, a winged housing, non-DEHP PVC extension legs, and a luer standard connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system or other selected body site
Indicated Patient Age Range
any patient
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)
The following non-clinical tests were performed as the basis for establishing substantial equivalence to the predicate device, as well as safety and effectiveness of the indication for use:
- Sterilization exposure; Sample Size: All; Test Description: The samples shall be exposed to a 2x EtO sterilization cycle.; Required Results: All samples must be capable of withstanding a 2X sterilization cycle.
- Physiological exposure; Sample Size: All; Test Description: Maintain samples in a 0.9% saline bath at 37°C for 24hrs prior to testing and between any tests. During the initial 24 hour preconditioning, the samples shall be flushed and locked with a Vancomycin solution (1g/1000cc of normal saline).; Required Results: All samples must be capable of withstanding physiological conditioning.
- Power injection Performance Test; Sample Size: 18; Test Description: Inject 200 ml of an 11.8 cP solution through the port at 5ml/sec. Evaluate system for leaks and damage; Required Results: Maximum Pressure: (U-X)/s >= k where k=1.96 for an AQL level of 0.65; Catheter material failure: no bursts. leaks, / plastic deformations allowed.
- Simulated Power Injection; Sample Size: 30; Test Description: Inject 150 ml of an 11.8 cP solution through the port at 5ml/sec with 19 Ga and 20 Ga needles. Evaluate system for leaks and damage; Required Results: All samples must meet expected flow rate and pressure withstand requirements.
- Dynamic Failure Test; Sample Size: 18; Test Description: Inject 200 ml an 11.8 cP solution through the port at increasing flow rates until failure occurs.; Required Results: Data shall be gathered to support label claims and determine the operational safety factor.
- Static Burst Test; Sample Size: 18; Test Description: Inject 100ml of a saline solution through the port with the catheter occluded. Record the maximum pressure; Required Results: Data shall be gathered to support label claims.
- Life Cycle Power Injection Test; Sample Size: 10; Test Description: Inject 200 ml of an 11.8 cP solution through the port at 5ml/sec. Evaluate system for leaks and damage. Repeat the test 9 times; Required Results: Catheter material failure: no bursts, leaks, / plastic deformations allowed.
- Cyclic testing; Sample Size: 30, 10 cycles per port; Test Description: Inject 150 ml of an 11.8 cP solution through the port at 5ml/sec with 19 Ga needles. Repeat cycle 10 times. Evaluate system for leaks and damage.; Required Results: All samples must withstand 10 cycles without leaking or bursting, The expected maximum number of power injection cycles is 5.
- Port Patency Verification; Sample Size: 5; Test Description: Withdraw simulated blood through port needle combination to determine flow rate of fully patent system.; Required Results: Blood return must be easily and empirically verifiable to establish safety of power injection.
- Port Occlusion Test; Sample Size: 10; Test Description: Inject 100ml of a saline solution through the port with the catheter occluded. Record the maximum pressure; Required Results: Data shall be gathered to support label claims.
- Puncture Life; Sample Size: 2; Test Description: To test the durability of the septum with needles expected to be used in power injection.; Required Results: Establish label claim for largest needle likely to be used during power injection.
Conclusions drawn from the non-clinical performance data: The non-clinical tests demonstrate that the device is as safe, as effective for the modified intended use.
No clinical tests were performed to determine substantial equivalence.
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.
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
§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.
0
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5.0 510(k) Summary
Manufacturer and sponsor of the 510(k)
RITA Medical Systems, Inc. One Horizon Way Manchester, Georgia 31816 800-472-5221 Phone 706-846-5226 fax Establishment registration number: 1056436
Device Identification:
| Proprietary Name: | Vortex® CT Port Access System |
|---|---|
| Common Name: | Vascular access port |
| Classification Name: | Subcutaneous, implanted, intravascular infusion port & |
| catheter | |
| Classification Number: | 21 CFR §880.5965 |
| Classification Panel: | General Hospital |
| Product Code: | LJT |
| Regulatory Class: | II |
| Proprietary Name: | LifeGuard® Safety Infusion Set |
| Common Name: | Port Access Infusion set |
| Classification Name: | Set, administration, intravascular |
| Classification Number: | 21 CFR §880.5440 |
| Classification Panel: | General Hospital |
| Product Code: | FPA |
| Regulatory Class: | II |
Legally marketed device to which equivalence is claimed:
C.R. Bard PowerPort 510(k) K060812
Primary contact for correspondence
David Smith Director of Engineering 800-472-5221 ext. 3085 voice 706-846-5226 fax dsmith@ritamed.com
Secondary contact
Karen Alexander Director of Regulatory Affairs 800-472-5221 ext. 3023 voice 706-846-5303 fax kalexander@ritamed.com
Page 13 of 78
Kd62414 Pg 1 of 8
- 1 2007
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K06 2414 Pg 2 of 8
Device Description
The legally marketed devices that form the basis for this 510(k) submission is Horizon Medical Products' Vortex® Access System (K010767 cleared April 10, 2001), and the LifeGuard safety infusion set K013871 cleared March 6, 2002).
The Vortex® CT Port is a Titanium port with a self sealing silicone rubber septum designed to maintain integrity after punctures with a non-coring needle. The port has a hollow area, or reservoir, under the septum through which fluid passes during infusion or aspiration.
The Vortex design features a proprietary reservoir with rounded walls giving it a toroidal shape. The outlet stem is located tangential to the reservoir wall allows fluid to pass between the reservoir and the catheter.
The Vortex® Port Access systems offer models with single lumen 7.5 French to 9.6 French catheters made from either polyurethane or silicone. The catheters all contain radiopacifiers, and depth markings.
A more detailed description of the components of the Vortex® Port Access System is as follows;
Port Body: The body of the port is crafted of Titanium. Suture sites are incorporated into the port base to facilitate anchoring to the underlying tissue.
Reservoir: The reservoir is the hollow area under the septum, into which the non-coring needle is inserted for administration or withdrawal of fluids. The toroidal wall shape and a tangential outlet stem interface to facilitate flushing of the system.
Outlet stem: The port outlet stem is made from Titanium. Connection to the stem is accomplished through barbed connectors. The stem is located tangentially to the reservoir. The catheter is placed over stem, and locked into place. This creates a fluid connection with the reservoir.
Port septum: The port septum is the component through which the non-coring needle is inserted. The septum is self sealing, designed to maintain integrity after repeated punctures and is constructed from silicone (NuSil MED 4850).
Catheter: The available catheters are 7.5 or 9.6 French made from silicone (NuSil MED 4765) impregnated with a 15% BaSO4 in the cannula. The catheters include a blue stripe and tip loaded 25% BaSO4 for improved radiopacity. All catheters have depth markings to 65 cm to allow for precise placement.
Locking Mechanism: The cylindrical locking mechanism is made from silicone. The lock is advanced over the catheter until it positively locks onto the port stem, thereby compressing the catheter onto the stem and sealing the system.
Page 14 of 78
2
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Implantation: The Vortex® Port Access System is totally implanted in the body. The catheter is placed by percutaneous puncture technique with the distal tip at the juncture of the superior vena cava and right atrium via the jugular or subclavian vein. A subcutaneous pocket is prepared for placement of the port. The appropriate catheter length is determined, and the excess is trimmed by cutting straight across the proximal end. The catheter is marked up to 65 cm to allow more precise placement in the desired location. The catheter is attached to the port using the locking mechanism. The port body is secured by suturing through the base to the underlying fascia prior to wound closure.
The Vortex® port has significant physical and performance characteristics that make it an ideal candidate for indication for power injection. These characteristics include; All Titanium construction for maximum strength, barbed outlet stems for ease and simplicity of catheter connection, and maximum connection strength, combination locking mechanism / strain relief for simple locking, and maximum catheter protection.
The LifeGuard safety infusion set is a port access needle set with an integrated proprietary safety feature to prevent re-bound injury. The safety infusion set includes a huber needle, a winged housing, non-DEHP PVC extension legs, and a luer standard connector.
It has come to RITA's attention that ports have and are being used for power injection studies. RITA currently makes no claims, and provides no instructions for this procedure. The purpose of this 510(k), and the studies which have been conducted, is to establish a safe and effective way to conduct a power injection study through ports which are deemed to be appropriate for this type of use.
When used for power injection, the port is accessed, using qualified infusion sets, in the standard fashion, per the standard instructions. The supplemental instructions will then be followed for power injection. Power injection involves the use of a power syringe to inject contrast media in order to complete a study.
Intended Use / Indications
The Vortex® CT Port Access System is indicated for any adult patient requiring repeated access of the vascular system or other sclected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood,
The Vortex® CT ports can accommodate a 5 ml/see injection rate of contrast dye. This should only be attempted using a 20 gauge or 19 gauge non-Y site LifeGuard® in Ision set model #'s LG-19-XXX, and LG-20-XXX.
Page 15 of 78
။ အိမ္း အသိန္းမွန္းမွာေရးမွာ ျပန္မားမာေတာင္းမွာ များမွန္မွာ ျပန္မာျဖစ္မွ ျပန္မာျဖစ္ေျပာင္း ေျခင္း
3
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Pre-market Notification -510(k) RITA Medical Systems, Inc. Vortex® CT Power Injectable Port Access System - August 14, 2006
Summary of the technological characteristics of your device compared to the predicate device
The following table summarizes the technological comparison between the Vortex® CT and Bard PowerPort:
| Technological Characteristic | RITA Vortex™ CT | C.R. Bard PowerPort (K060812) |
|---|---|---|
| Intended use, power injection | Accommodates a 5 ml/sec | |
| injection rate of contrast dye. This | ||
| should only be attempted using a | ||
| 20 gauge or larger non-Y site | ||
| LifeGuard* CT infusion set. | Accommodates a 5 ml/sec | |
| injection rate of contrast dye | ||
| injected at up to 300 psi without | ||
| damaging the port or catheter. | ||
| Design | Port system with attachable | |
| catheter. | Port system with attachable | |
| catheter. | ||
| Material | Titanium Grade 2 | Titanium |
| Shape | Round port system with tangential | |
| outlet | Triangular port system with central | |
| outlet | ||
| Included labeling | Instructions for use (General) | |
| Instructions for use power | ||
| injection | ||
| Vortex™ CT poster for CT offices | ||
| Patient information booklet | ||
| Patient ID card with key fob | ||
| Patient chart labeling | ||
| Product label | Educational booklet for patients, | |
| nurses, placers, and CT department | ||
| Wall charts for CT department and | ||
| placers | ||
| Discharge kits for patients | ||
| (includes Patient ID card with key | ||
| fob and bracelet) | ||
| Needles used for Access | LifeGuard non-Y site safety | |
| infusion sets in 19 or 20 Ga | LiftLock non-Y site safety infusion | |
| sets in 19 or 20 Ga |
ი ინტერნეტში
Page 16 of 78
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K062414 Pg 5 of 8
Summary of the non-clinical performance data
:
.
The following non-clinical tests were performed as the basis for establishing substantial equivalence to the predicate device, as well as safety and effectiveness of the indication for use:
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5
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Pre-market Notification -510(k)
RITA Medical Systems, Inc.
Vortex® CT Power Injectable
Portex® CT Power Injectable
Port Access System -- August 14, 2006
| Test
Description | Sample
Size | Test Description | Required Results |
|----------------------------------------|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization
exposure | All | The samples shall be exposed to a 2x EtO
sterilization cycle. | All samples must be capable of
withstanding a 2X sterilization cycle |
| Physiological
exposure | All | Maintain samples in a 0.9% saline bath at 37°C for
24hrs prior to testing and between any tests.
During the initial 24 hour preconditioning, the
samples shall be flushed and locked with a
Vancomycin solution (1g/1000cc of normal
saline). | All samples must be capable of
withstanding physiological
conditioning |
| Power injection
Performance
Test | 18 | Inject 200 ml of an 11.8 cP solution through the
port at 5ml/sec. Evaluate system for leaks and
damage | Maximum Pressure: $(U-X)/s ≥ k$
where k = 1.96 for an AQL level of
0.65
Catheter material failure: no bursts.
leaks, / plastic deformations allowed |
| Simulated
Power Injection | 30 | Inject 150 ml of an 11.8 cP solution through the
port at 5ml/sec with 19 Ga and 20 Ga needles.
Evaluate system for leaks and damage | All samples must meet expected
flow rate and pressure withstand
requirements |
| Dynamic
Failure Test | 18 | Inject 200 ml an 11.8 cP solution through the port at
increasing flow rates until failure occurs. | Data shall be gathered to support
label claims and determine the
operational safety factor. |
| Static Burst
Test | 18 | Inject 100ml of a saline solution through the port
with the catheter occluded. Record the maximum
pressure | Data shall be gathered to support
label claims. |
| Life Cvcle
Power Injection
Test | 10 | Inject 200 ml of an 11.8 cP solution through the
port at 5ml/sec. Evaluate system for leaks and
damage. Repeat the test 9 times | Catheter material failure: no bursts,
leaks, / plastic deformations allowed |
| Cyclic testing | 30, 10
cycles per
port | Inject 150 ml of an 11.8 cP solution through the
port at 5ml/sec with 19 Ga needles. Repeat cycle
10 times. Evaluate system for leaks and damage. | All samples must withstand 10
cycles without leaking or bursting,
The expected maximum number of
power injection cycles is 5. |
| Port Patency
Verification | 5 | Withdraw simulated blood through port needle
combination to determine flow rate of fully patent
system. | Blood return must be easily and
empirically verifiable to establish
safety of power injection |
| Port Occlusion
Test | 10 | Inject 100ml of a saline solution through the port
with the catheter occluded. Record the maximum
pressure | Data shall be gathered to support
label claims. |
| Puncture Life | 2 | To test the durability of the septum with needles
expected to be used in power injection. | Establish label claim for largest
needle likely to be used during
power injection |
·
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Kob 24/14 pg 7 of 8
Summary of the clinical performance data
No clinical tests were performed to determine substantial equivalence.
:
Page 19 of 78
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K062414 pg 8of8
Conclusions drawn from the non-clinical performance data
The non-clinical tests demonstrate that the device is as safe, as effective for the modified intended use.
Page 20 of 78
.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David Smith Director, of Vascular Products Engineering RITA Medical Systems, Incorporated One Horizon Way Manchester, Georgia 31816
FEB - 1 2007
Re: K062414
Trade/Device Name: Vortex® CT Port Access Systems and LifeGuard® Safety Infusion Set Regulation Number: 880.5965 Regulation Name: Subcutaneous, Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT, FPA Dated: January 24, 2007 Received: January 25, 2007
Dear Mr. Smith:
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 Federal Register.
9
Page 2 - Mr. Smith
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 (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.
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-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clars
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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Pre-market Notification response -- 510(k) # K062414 RITA Medical Systems, Inc. Vortex® CT Power Injectable Port Access System
The LifeGuard® Safety Administration Set intended use has been reproduced below in the FDA's required format.
Indications for Use
510(k) Number (if known): K062414
LifeGuard® Safety Infusion Set Device Name:
Indications for Use:
The LifeGuard® Safety Infusion Sct is an administration set with a non-coring right angle needle and manually activated needle-stick prevention safety mechanism. The device is used to access surgically implanted vascular ports.
The LifeGuard® Safety Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.
When used with the Vortex® CT Port Access System, the LifeGuard® Safety Infusion Set is also indicated for power injection of contrast media into the central venous system. For power injection of contrast media, only models LG-19-75, LG-19-100, LG-20-75, LG-20-100, and LG-20-150 may be used at a maximum infusion rate of Sml/sec.
Prescription Use AND/OR X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807
Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anthony D. Watson
Page 4 of 34
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Indications for Use Statement 4.0
The Vortex® CT Port Access System intended use has been reproduced below in the FDA`s required format.
Indications for Use
510(k) Number (if known): K062414
Vortex® CT Port Access System Device Name:
Indications for Use:
The Vortex® CT Port Access System is indicated for any patient requiring repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and the sampling of blood.
When used with non Y site LifeGuard Safety infusion sets in 20 Ga or 19Ga sizes, the Vortex® CT Port Access System is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec.
Prescription Use X X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpari C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
itz Lont
1462414
and and the britain and the comments of the first of the count
Page 11 of 78
이 부분했다. 이 지역 1915년 1975년 1975년 1975년 1975년 1975년 1975년 1975년 1975년 1975년 1975년 1975년 1975년 1975년 1975년 1975년 1975년 1975년 1975년 1975년 1975년 1975년 1975
이 이용 (1) 이름을 하고 있다. 이