(268 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a reprocessed needle, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used to puncture the interatrial septum to gain left heart access, which is a procedural step rather than a therapeutic intervention itself. It facilitates access for other procedures but does not treat a condition.
No
The device is used to puncture the interatrial septum to gain left heart access for a catheterization procedure, which is an interventional/surgical function, not a diagnostic one. While it allows for blood sampling and pressure monitoring, its primary function as described is mechanical access.
No
The device description clearly outlines a physical medical device made of stainless steel with specific mechanical features and intended for a physical procedure (puncturing the interatrial septum). The performance studies also focus on physical characteristics and processes like sterilization, cleaning, and mechanical testing, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access. This is a surgical/interventional procedure performed directly on the patient's body.
- Device Description: The device is a physical needle and stylet designed for mechanical action within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a procedural purpose.
N/A
Intended Use / Indications for Use
The Reprocessed BRK Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.
Product codes (comma separated list FDA assigned to the subject device)
NMK
Device Description
The reprocessed BRK Transseptal Needle consists of a luminal stainless steel needle and solid stainless steel stylet. The distal section of the needle is curved to facilitate positioning within the heart when used with a St. Jude Medical transseptal introducer set. Within this curved section, there is an abrupt step down in the outer diameter of the needle to mate with the internal diameter of the dilator of a St. Jude Medical transseptal introducer set. The distal tip of the needle is beveled to facilitate the puncture process. The proximal end of the needle is configured with a pointer flange (indicating distal curve orientation) and is fitted with a 2-way stopcock to provide needle lumen access for aspiration, fluid injection/infusion, blood sampling, pressure monitoring, and stylet and/or guidewire insertion (0.014" maximum guidewire diameter for an 18 gauge needle). The stylet is straight and isodiametric throughout its length. The proximal end of the stylet is fitted with a curved clip to lock onto the proximal needle hub when inserted into the needle lumen. The stylet is designed to facilitate needle advancement within the dilator. The reprocessed needle is available in various useable lengths and distal curve configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
interatrial septum, heart
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)
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed BRK Transseptal Needle. This included the following:
- Biocompatibility
- Cleaning Validation
- Sterilization Validation
- Functional Testing
. Visual Inspection
. Dimensional Verification
. Simulated Use
. Leak Testing
. Mechanical Characteristics
. Corrosion Resistance - Packaging Validation
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
§ 870.1390 Trocar.
(a)
Identification. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.(b)
Classification. Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 22, 2020
Innovative Health, LLC. Ms. Amanda Babcock Regulatory Affairs Manager 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257
Re: K192998
Trade/Device Name: Reprocessed BRK Transseptal Needle Regulation Number: 21 CFR 870.1390 Regulation Name: Trocar, Reprocessed Regulatory Class: Class II Product Code: NMK Dated: June 12, 2020 Received: June 15, 2020
Dear Amanda Babcock:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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The model numbers in the scope of this clearance are as follows.
- BRK Transseptal Needle Model Numbers 407200, 407201, 407205, G407215, 407206, 407207 ●
- BRK XS Transseptal Needle Model Numbers G407209, G407210, G407210, G407216, G407211, . G407212
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Indications for Use
510(k) Number (if known) K192998
Device Name Reprocessed BRK Transseptal Needle
Indications for Use (Describe)
The Reprocessed BRK Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K192998
510(k) SUMMARY
As required by 21 CFR 807.92(c)
Submitter's Name and Address:
Innovative Health, LLC. 1435 N. Hayden Road, Suite 100 Scottsdale, AZ 85257
Contact Name and Information:
Amanda Babcock Regulatory Affairs Manager Innovative Health, LLC. (480) 525-5911 (office) (888) 965-7705 (fax) ababcock@innovative-health.com
Date prepared:
July 22, 2020
Device Information:
Trade/Proprietary Name: | Reprocessed BRK Transseptal Needle |
---|---|
Common Name: | Transseptal Needle |
Classification Name: | Trocar, reprocessed |
Classification Number: | Class II, 21 CFR §870.1390 |
Product Code: | NMK |
Predicate Device:
510(k) Number | 510(k) Device | Manufacturer |
---|---|---|
K122587 | BRK Transseptal Needle | St. Jude Medical |
K072278 | BRK Transseptal Needle | St. Jude Medical |
Reference Device:
510(k) Number | 510(k) Device | Manufacturer |
---|---|---|
K172950 | TSN Transseptal Needle | Pressure Products Medical Device |
Manufacturing LLC |
Device Description:
The reprocessed BRK Transseptal Needle consists of a luminal stainless steel needle and solid stainless steel stylet. The distal section of the needle is curved to facilitate positioning within the heart when used with a St. Jude Medical transseptal introducer set. Within this curved section, there is an abrupt step down in the outer diameter of the needle to mate with the internal diameter of the dilator of a St. Jude Medical transseptal introducer set. The distal tip of the needle is beveled to facilitate the puncture process. The proximal end of the needle is configured with a pointer flange (indicating distal curve orientation) and is fitted with a 2-way stopcock to provide needle lumen access for aspiration, fluid injection/infusion, blood sampling, pressure monitoring, and stylet and/or guidewire insertion (0.014" maximum guidewire diameter for an 18 gauge needle). The stylet is straight and isodiametric throughout its length. The proximal end of the stylet is fitted with a curved clip to lock onto the proximal needle hub when inserted into the needle lumen. The stylet is designed to facilitate needle advancement within
5
the dilator. The reprocessed needle is available in various useable lengths and distal curve configurations.
| Description | Item
Number | Needle
Gauge
Size | Bevel
Angle | Curve Type | Max
OD
(mm) | Min ID
(mm) | Usable
Length
(cm) |
|----------------------------------|----------------|-------------------------|----------------|------------|-------------------|----------------|--------------------------|
| BRK
Transseptal
Needles | 407200 | 18 ga | 50° | BRK | 1.3 | 0.50 | 71 |
| | 407201 | 18 ga | 50° | BRK-1 | 1.3 | 0.50 | 71 |
| | 407205 | 18 ga | 50° | BRK | 1.3 | 0.50 | 89 |
| | G407215 | 18 ga | 50° | BRK-1 | 1.3 | 0.50 | 89 |
| | 407206 | 18 ga | 50° | BRK | 1.3 | 0.50 | 98 |
| | 407207 | 18 ga | 50° | BRK-1 | 1.3 | 0.50 | 98 |
| BRK XS
Transseptal
Needles | G407208 | 18 ga | 30° | BRK XS | 1.3 | 0.50 | 71 |
| | G407209 | 18 ga | 30° | BRK-1 XS | 1.3 | 0.50 | 71 |
| | G407210 | 18 ga | 30° | BRK XS | 1.3 | 0.50 | 89 |
| | G407216 | 18 ga | 30° | BRK-1 XS | 1.3 | 0.50 | 89 |
| | G407211 | 18 ga | 30° | BRK XS | 1.3 | 0.50 | 98 |
| | G407212 | 18 ga | 30° | BRK-1 XS | 1.3 | 0.50 | 98 |
The item numbers in scope of this submission are as follows:
Indications for Use:
The Reprocessed BRK Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.
Technological Characteristics:
The purpose, design, materials, function, and intended use of the Reprocessed BRK Transseptal Needle are identical to the predicate device. There are no changes to the claims, clinical applications, patient population, performance specifications, or method of operation. In addition, Innovative Health's reprocessing of this device includes removal of visible soil and decontamination. Each device is inspected and function tested prior to packaging and labeling.
Functional and Safety Testing:
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed BRK Transseptal Needle. This included the following:
- Biocompatibility ●
- Cleaning Validation ●
- Sterilization Validation ●
- Functional Testing ●
- . Visual Inspection
- Dimensional Verification .
- Simulated Use .
- Leak Testing .
- Mechanical Characteristics .
- Corrosion Resistance .
- Packaging Validation ●
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The Reprocessed BRK Transseptal Needle is reprocessed no more than one (1) time. Each device is serialized and tracked. After the device has reached the maximum number of reprocessing cycles, the device is rejected from further reprocessing. Reprocessing is performed only by Innovative Health. Innovative Health restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.
Conclusion:
Innovative Health concludes that the Reprocessed BRK Transseptal Needle is as safe and effective as the predicate device described herein.