Search Results
Found 2 results
510(k) Data Aggregation
(89 days)
The OnControl™ Bone Marrow Biopsy System is intended for bone marrow aspiration and biopsy.
The OnControl™ Bone Marrow Biopsy System consists of a reusable battery powered driver (similar to the one cleared for bone marrow aspiration in adults via K062833) connected to a disposable bone marrow biopsy needle set. The 11 gauge, 152mm cannula is identical in gauge and length to the predicate InterV® TrapLok, cleared via K043523. The BioAccess Bone Marrow Harvest System is an FDAcleared powered biopsy device (K953064), which has a battery power source similar to Vidacare's product. Upon activation, the driver assists the clinician to insert a biopsy needle set through the cortex of the bone. The driver is then separated from the hub of the biopsy needle set by retracting the collar on the driver - coupler. The trocar/stylet is then removed from the needle set leaving な an 11-gauge biopsy cannula firmly seated in the bone. A standard Luer lock (part of the 11 gauge cannula) then permits attachment of a standard syringe for aspiration of bone marrow. The driver/coupler is then reattached to the biopsy cannula and the power driver is activated. The biopsy cannula is advanced to the desired depth in the medullary cavity for capturing adequate bone marrow biopsy samples. The entire needle assembly is then withdrawn from the patient using power to facilitate removal. At this point the driver is separated from the biopsy needle assembly; the specimen is removed from the biopsy cannula by attaching an alignment guide to the cutting end of the biopsy cannula and pushing out the bone specimen with an ejector rod. The cannula length is 152mm (6"), which is identical to the predicate InterV® TrapLok, K043523.
The provided text is a 510(k) summary for the OnControl™ Bone Marrow Biopsy System. It describes the device, its intended use, and its equivalence to predicate devices. However, it does not contain information about acceptance criteria or a specific study that proves the device meets those criteria.
510(k) submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against pre-defined acceptance criteria through a specific clinical study in the same way a PMA (Premarket Approval) submission would.
Therefore, I cannot provide the requested information from the given text.
The document states:
- "The predicates and the OnControl™ Bone Marrow Biopsy System were compared in the following areas and found to have similar technological characteristics and to be equivalent."
- "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..."
This indicates that the review focused on demonstrating equivalence in design, indications for use, and technological characteristics to existing devices, not on meeting new, specified performance criteria through a dedicated study.
Ask a specific question about this device
(62 days)
For Bone Marrow Aspiration of the Iliac Crest in pediatric patients.
The Powered EZ-IO® Pediatric Bone Marrow Aspiration System consists of a reusable battery powered driver [previously cleared for aspiration in adults via 510(k) K062833], and a 25mm intraosseous (IO) device fcleared under 510(k) K032885] connected to a disposable, single use intraosseous aspiration needle set assembly. Upon activation, the drill assists the operator with needle set insertion into the bone. The driver is then separated from the hub of the needle set assembly, leaving the needle set securely seated in the bone. The trocar/stylet is then removed from the needle set leaving the 15 gauge catheter. A standard Luer lock (part of the catheter hub) then permits attachment of standard syringe for aspirating bone marrow samples. The needle set is 25mm in length [previously cleared for IO use in adults via 510(k] number K032885). This submission does not include new devices; it only requests new indications for use of the 510(k) device listed above as an aspiration product for pediatric applications.
It seems there's a misunderstanding in the request or the provided document. The provided text is a 510(k) summary for the "Powered EZ-IO Pediatric Bone Marrow Aspiration System." A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria, test sets, ground truth establishment, or multi-reader multi-case studies, as would be expected for a novel AI/software-as-a-medical-device.
The document states: "This submission does not include new devices; it only requests new indications for use of the 510(k) device listed above as an aspiration product for pediatric applications." It further emphasizes that the device was compared to predicates and found to have "similar technological characteristics and to be equivalent" in several areas.
Therefore, the information requested in points 1-9 (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the provided 510(k) summary because this type of detailed performance study is not typically required or included for a 510(k) seeking a new indication for an already cleared device through substantial equivalence.
Based on the provided text, I can extract the following relevant information, but I cannot fulfill the request for a detailed performance study description:
Summary of Device and Regulatory Status:
- Device Name: Powered EZ-IO® Pediatric Bone Marrow Aspiration System
- Submitter: Vidacare Corporation
- 510(k) Number: K070759
- Date Prepared: March 16, 2007
- Classification Name: Gastroenterology-urology biopsy instrument
- Regulatory Class: II
- Product Code: FCF
- Predicate Devices:
Indications for Use:
- For Bone Marrow Aspiration of the Iliac Crest in pediatric patients.
Description of the Device:
- Consists of a reusable battery-powered driver (previously cleared for aspiration in adults via K062833) and a 25mm intraosseous (IO) device (cleared under K032885) connected to a disposable, single-use intraosseous aspiration needle set assembly.
- The driver assists with needle set insertion into the bone.
- Driver is separated, trocar/stylet removed, leaving a 15 gauge catheter.
- Standard Luer lock permits attachment of a syringe for aspirating bone marrow samples.
- The needle set is 25mm in length (previously cleared for IO use in adults via K032885).
Basis for Substantial Equivalence:
The technological characteristics of the Powered EZ-IO® Pediatric Bone Marrow Aspiration System were compared to the predicate devices and found to be similar and equivalent in the following areas:
- Indications for Use
- Target Population
- Driver Design Features
- Needle Design
- Technique
- Sterility
- Biocompatibility
- Anatomical Sites Where Used
In conclusion, for a 510(k) submission based on substantial equivalence for a new indication for an existing device, a detailed "study that proves the device meets the acceptance criteria" in the way you've described (with test sets, ground truth, experts, etc.) is not typically performed or presented. The primary evidence presented is the comparison to legally marketed predicate devices to demonstrate equivalent technological characteristics and safety/effectiveness.
Ask a specific question about this device
Page 1 of 1