(42 days)
Not Found
No
The summary describes a manually operated surgical instrument with no mention of AI, ML, or any computational processing.
No
The device is described as a manually operated surgical instrument used for aspirating bone marrow/blood or placing guidewires; it does not directly treat or mitigate a disease or condition. Its function is to facilitate other procedures.
No
The Imbibe Needle is described as a surgical instrument used for aspirating bone marrow or blood and for placing guidewires during orthopedic surgery. Its intended use focuses on procedural assistance rather than diagnosing a condition or disease.
No
The device description explicitly states it is a "manually operated surgical instrument," indicating it is a physical hardware device, not software only.
Based on the provided information, the Imbibe Needle is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for aspirating bone marrow or autologous blood by use of a syringe and for placing guidewires during orthopedic surgery. This is a direct surgical intervention on the patient's body.
- Device Description: It is described as a "manually operated surgical instrument."
- Lack of In Vitro Testing: There is no mention of the device being used to test samples outside of the body (in vitro). The aspirated bone marrow or blood is intended to be combined with bone graft or bone void filler, which is a therapeutic use, not a diagnostic test.
- Performance Studies: The performance studies focus on mechanical and cadaveric testing, demonstrating its ability to assist in surgical procedures, not on the accuracy or reliability of a diagnostic test.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro to provide information for diagnostic, monitoring, or compatibility purposes. The Imbibe Needle's function is to obtain a sample and facilitate a surgical procedure, not to perform a diagnostic test on that sample.
N/A
Intended Use / Indications for Use
The Imbibe Needle is for use in aspirating bone marrow or autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler.
The Imbibe Needle is also for use in the placement of guidewires (e.g. k-wires) during orthopedic surgery.
Product codes (comma separated list FDA assigned to the subject device)
KNW, LXH
Device Description
The Imbibe Needle is a manually operated surgical instrument to assist with the aspiration of autologous blood or bone marrow and/or placing guidewires (e.g. kwires) for orthopedic surgery. These guidewires may be used to place other hardware utilized in orthopedic procedures including pedicle screws.
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)
Preclinical bench data supplied including mechanical and cadaveric testing demonstrates that the Imbibe Needle is substantially equivalent to the predicate device and any differences do not raise new questions of safety and effectiveness. Further, this testing supports the Imbibe Needle's ability to assist in the placement of guidewires.
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
§ 888.4540 Orthopedic manual surgical instrument.
(a)
Identification. An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
APR 0 1 2014
510(k) SUMMARY Stryker Imbibe Needle
February 18th, 2014
K140414 510(k) Number (if known):
1. Contact Person
John Urtz Senior Regulatory Affairs Specialist (e-mail) john.urtz@stryker.com
Orthovita, Inc. 77 Great Valley Parkway Malvern, PA 19355 (t) 610-407-7450 - (f) 484-323-8803
2. Device Name and Classification
Product Name: Classification Name:
Common or Usual Name: Regulation Number:
Reviewing Panel:
Device Class: Product Code: Imbibe Needle Instrument, Biopsy Orthopedic Manual Surgical Instrument Gastroenterology-urology biopsy instrument 876.1075 888.4540 Gastroenterology/Urology Surgical, Orthopedic, and Restorative Devices Class II KNW LXH
3. Predicate Device(s)
Orthovita Inc.'s Imbibe Needle (K050795)
4. Device Description
The Imbibe Needle is a manually operated surgical instrument to assist with the aspiration of autologous blood or bone marrow and/or placing guidewires (e.g. kwires) for orthopedic surgery. These guidewires may be used to place other hardware utilized in orthopedic procedures including pedicle screws.
5. Indications for Use
The Imbibe Needle is for use in aspirating bone marrow or autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler.
The Imbibe Needle is also for use in the placement of guidewires (e.g. k-wires) during orthopedic surgery.
1
6. Performance Data
ﺎﻧﻴﺔ ﺍﻟﺘﻲ
Preclinical bench data supplied including mechanical and cadaveric testing demonstrates that the Imbibe Needle is substantially equivalent to the predicate device and any differences do not raise new questions of safety and effectiveness. Further, this testing supports the Imbibe Needle's ability to assist in the placement of guidewires.
7. Substantial Equivalence
| | Imbibe Needle
Predicate Device
K050795 | Imbibe Needle
New Device
TBD |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INDICATIONS FOR
USE | The Imbibe Needle is for use in
aspirating Bone Marrow or
autologous blood by use of a
syringe. The bone marrow or
autologous blood may be combined
with bone graft or bone void filler. | The Imbibe Needle is for use in
aspirating bone marrow or autologous
blood by use of a syringe. The bone
marrow or autologous blood may be
combined with bone graft or bone void
filler.
The Imbibe Needle is also for use in
the placement of guidewires (e.g. k-
wires) during orthopedic surgery. |
| PRODUCT CODE | KNW | KNW, LXH |
| PRODUCT DESIGN | Handle with cannula, removable | Handle with cannula, removable stylet |
| STYLET TIP DESIGN | Trocar | Trocar, Beveled |
| FENESTRATED
OFFERING | Y es | Yes |
| MALE LUER
CONNECTION FOR
SYRINGE
ATTACHMENT | Yes | Yes |
| STERILIZATION AND
SAL | Gamma irradiation, 10-6 | Gamma irradiation, 10-6 |
| BIOCOMPATIBILITY | Externally communicating device
with tissue/blood/dentin contact for
a duration of less than 24 hours | Externally communicating device with
tissue/blood/dentin contact for a
duration of less than 24 hours |
27
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's name encircling a symbol. The symbol is a stylized representation of an eagle or bird-like figure, with three curved lines forming the body and wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Dacument Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 1, 2014
Orthovita Incorporated Mr. John Urtz Senior Regulatory Affairs Specialist 77 Great Valley Parkway Malvern, Pennsylvania 19355
Re: K140414
Trade/Device Name: Imbibe Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW, LXH Dated: February 18, 2014 Received: February 18, 2014
Dear Mr. Urtz:
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 cither 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Hoo master and regulations administered by other Federal agencies. You must Or any I cachar statines and regiraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Cl N F art 6077, abouting (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. John Urtz
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aquel
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):_K140414
Device Name: Imbibe Needle
Indications for Use:
The Imbibe Needle is for use in aspirating bone marrow or autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler.
The Imbibe Needle is also for use in the placement of guidewires (e.g. k-wires); during orthopedic surgery.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR Over-The Counter Use x (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
Felipe Aguel
Date: 2014.04.01 16:08:02 -04'00'