(602 days)
No
The device description focuses on mechanical components and electrical control for rotation, with no mention of AI/ML terms or functions.
No
The "Intended Use / Indications for Use" section explicitly states, "This device is for diagnostic purposes only." Therapeutic devices are used for treatment, not just diagnosis.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This device is for diagnostic purposes only."
No
The device description clearly outlines multiple hardware components including a handle, flexible sheath, cylinder tip, outer sheath, reusable electrical motor, drive cable, and pedal. It is a physical biopsy instrument.
Based on the provided information, the EndoDrill® Model X is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnostic purposes.
- EndoDrill® Model X Function: The EndoDrill® Model X is a biopsy instrument used to collect tissue samples from within the gastrointestinal tract. While these samples are intended for diagnostic purposes, the device itself is the tool for acquisition, not the tool for analysis of the sample.
- Device Description: The description focuses on the mechanical aspects of tissue collection (rotating cylinder tip, sheath, handle, motor). It does not describe any components or processes for analyzing the collected tissue.
- Intended Use: The intended use states it's for "ultrasonically guided fine needle sampling... for diagnostic purposes only." This reinforces its role in sample collection for subsequent diagnosis, not the diagnosis itself.
In summary, the EndoDrill® Model X is a device used to obtain a sample that will then be analyzed by an IVD device or other diagnostic methods. It is a sample collection device, not an IVD.
N/A
Intended Use / Indications for Use
The EndoDrill® Model X is intended to be used with an ultrasound endoscope for ultrasonically guided fine needle sampling of submucosal- and extramural lesions within gastrointestinal tract (i.e. esophagus, mediastinal masses, stomach, pancreas, liver, small- and large intestines, lymph nodes and perirectal masses). This device is for diagnostic purposes only.
Product codes
FCG
Device Description
The EndoDrill® Model X biopsy instrument consists of a single-use handle with a flexible sheath and a cylinder tip that can be rotated to collect tissue samples. An outer sheath covers the tip to facilitate smooth insertion, positioning of the instrument and extraction. The hollow cylinder allows for multiple samples being taken continuously without removing the instrument for harvesting between biopsies. Rotation is facilitated by an isolated reusable electrical motor controlled by the user. No current, heat, smoke or sparks are introduced into the patient.
The device is designed to be used in flexible endoscopic instruments with ultrasound (EUS) used for examinations of the gastrointestinal tract.
The single-use biopsy instrument consists of a needle and handle that are supplied sterile and is for single patient use only. The needle contains all patient contact pathways and is fully disposable. Cleaning, reprocessing and/or re- sterilization of the instrument is prohibited. The needle is inserted through the working channel of a flexible endoscope and fixed at the endoscope handle. The single-use and handle consists of the following pre-assembled, sterile components:
-
- A biopsy needle consisting of stainless-steel with a coring cylinder tip collecting samples in a fluid- and airtight tubing when rotated.
-
- An outer sheath that surrounds the rotating needle and may be used to place the inner needle at the biopsy site.
-
- A handle that is mounted to the working channel of an endoscope, used to control sampling and attaches to a reusable drive cable that mechanically transfers rotation.
The reusable electrical motor and drive cable facilitating the rotation of the tip are supplied non-sterile and reusable. The motor unit contains an on/off safety switch and rotation is activated with a pedal attached to the motor. The drive cable that mechanically transmits rotation to the needle is mounted on the handle prior to sampling. The motor unit accommodates a DC motor which includes a power indicator light and attachments for power cable, drive cable and pedal. The motor is isolated and provides mechanical rotation to the single-use handle via the drive cable. No current, heat, smoke or sparks are introduced into the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Gastrointestinal tract (i.e. esophagus, mediastinal masses, stomach, pancreas, liver, small- and large intestines, lymph nodes and perirectal masses)
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: Non-clinical (bench) testing.
Sample Size: Not specified.
Key Results: The EndoDrill® Model X System meets applicable ISO, and FDA safety and performance standards. The device performs safely and as intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
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March 29, 2023
Bibbinstruments AB % John Smith Partner Hogan & Lovells US LPP 555 13th St. NW Washington, DC 20004
Re: K212423
Trade/Device Name: EndoDrill® Model X Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: FCG Dated: February 24, 2023 Received: February 24, 2023
Dear John 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. 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.
1
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 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 medical devices and radiation-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.
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212423
Device Name EndoDrill® Model X biopsy instrument
Indications for Use (Describe)
The EndoDrill® Model X is intended to be used with an ultrasound endoscope for ultrasonically guided fine needle sampling of submucosal- and extramural lesions within gastrointestinal tract (i.e. esophagus, mediastinal masses, stomach, pancreas, liver, small- and large intestines, lymph nodes and perirectal masses). This device is for diagnostic purposes only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) SUMMARY
| DATE | March 24, 2023 |
|---|---|
| SUBMITTER | Bibbinstruments AB |
| Medicon Village | |
| S-223 81 Lund | |
| SWEDEN | |
| CONTACT PERSON | Lotta Ljungberg |
| Director QA/RA Bibbinstruments AB | |
| Tel : +46 76 034 24 40 | |
| Lotta.Ljungberg@bibbinstruments.com | |
| DEVICE NAME | |
| Classification Name | Biopsy Instrument |
| Trade/Common Name | EndoDrill® Model X biopsy instrument |
| Classification | Class II |
| Product Code | FCG |
| Regulation Number | 21CFR876. 1075 |
| PREDICATE/REFERENCE DEVICES: | Olympus EZ Shot 3 Plus 19G, Single Use |
| Aspiration Needle, K180449 | |
| Boston Scientific Radial Jaw™ 4 Single-Use Hot | |
| Biopsy Forceps, K101657 | |
| INDICATIONS FOR USE: | The EndoDrill® Model X is intended to be used |
| with an ultrasound endoscope for ultrasonically | |
| guided fine needle sampling of submucosal- and | |
| extramural lesions within gastrointestinal tract | |
| (i.e. esophagus, mediastinal masses, stomach, | |
| pancreas, liver, small- and large intestines, lymph | |
| nodes and perirectal masses). This device is for | |
| diagnostic purposes only. |
4
DEVICE DESCRIPTION:
EndoDrill® Model X
The EndoDrill® Model X biopsy instrument consists of a single-use handle with a flexible sheath and a cylinder tip that can be rotated to collect tissue samples. An outer sheath covers the tip to facilitate smooth insertion, positioning of the instrument and extraction. The hollow cylinder allows for multiple samples being taken continuously without removing the instrument for harvesting between biopsies. Rotation is facilitated by an isolated reusable electrical motor controlled by the user. No current, heat, smoke or sparks are introduced into the patient.
The device is designed to be used in flexible endoscopic instruments with ultrasound (EUS) used for examinations of the gastrointestinal tract.
The single-use biopsy instrument consists of a needle and handle that are supplied sterile and is for single patient use only. The needle contains all patient contact pathways and is fully disposable. Cleaning, reprocessing and/or re- sterilization of the instrument is prohibited. The needle is inserted through the working channel of a flexible endoscope and fixed at the endoscope handle. The single-use and handle consists of the following pre-assembled, sterile components:
-
- A biopsy needle consisting of stainless-steel with a coring cylinder tip collecting samples in a fluid- and airtight tubing when rotated.
-
- An outer sheath that surrounds the rotating needle and may be used to place the inner needle at the biopsy site.
-
- A handle that is mounted to the working channel of an endoscope, used to control sampling and attaches to a reusable drive cable that mechanically transfers rotation.
The reusable electrical motor and drive cable facilitating the rotation of the tip are supplied non-sterile and reusable. The motor unit contains an on/off safety switch and rotation is activated with a pedal attached to the motor. The drive cable that mechanically transmits rotation to the needle is mounted on the handle prior to sampling. The motor unit accommodates a DC motor which includes a power indicator light and attachments for power cable, drive cable and pedal. The motor is isolated and provides mechanical rotation to the single-use handle via the drive cable. No current, heat, smoke or sparks are introduced into the patient.
The device description is complete, and no figures of the device are present.
5
TECHNOLOGICAL CHARACTERISTIC AND SUBSTANTIAL EQUIVALENCE:
The following table provides more detailed information regarding the basis for the determination of substantial equivalence:
| Parameter | Boston Scientific Single-
Use Hot Biopsy Forceps
(Predicate) | EndoDrill® Model X
(510k applicant) | Olympus EZ Shot 3 Plus
(Reference) | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Indications for use | These single-use biopsy
forceps are specifically
designed to collect tissue
endoscopically for
histologic examination.
These forceps should not
be used for any other
purpose than the intended
function. These Single-Use
Hot Biopsy Forceps are
intended to be used through
an endoscope to cauterize
and remove polyps and/or
tissue specimens
throughout the alimentary
tract. The alimentary tract
includes the esophagus,
stomach, duodenum,
jejunum, ileum and colon. | The EndoDrill® Model X is
intended to be used with an
ultrasound endoscope for
ultrasonically guided fine
needle sampling of
submucosal- and extramural
lesions within
gastrointestinal tract (i.e.
esophagus, mediastinal
masses, stomach, pancreas,
liver, small- and large
intestines, lymph nodes and
perirectal masses). This
device is for diagnostic
purposes only | This instrument has been
designed to be used with an
Olympus ultrasound
endoscope for ultrasonically
guided fine needle
aspiration (FNA) and fine
needle biopsy (FNB) of
submucosal and extramural
lesions within the
gastrointestinal tract (i.e.
pancreatic masses,
mediastinal masses,
perirectal masses and lymph
nodes). | |
| Device Regulatory
Classification | 21 CFR 876.4300 | 21 CFR 876.1075 | 21 CFR 876.1075 | |
| Product Code | KGE | FCG | FCG | |
| Device Class | 2 | 2 | 2 | |
| 510(k) number | K101657 | K212423 | K180449 | |
| Guidance method | Endoscopy-Optic | Endoscopy-Optic/Ultrasound | Endoscopy
Optic/Ultrasound | |
| Tip dimensions | 2,20 mm (14 Gauge) | 1,47 mm (17 Gauge) | 19-25 Gauge | |
| Method of tissue
dissection | Electrically heated forceps
cuts tissue | Electromechanically rotated
cylinder cuts tissue. | Manually moved beveled
needle tip cuts tissue | |
| Method of tissue
collection | Electrically heated forceps
cuts, severs and collects
tissue | Electromechanically rotated
cylinder cuts, severs and
collects tissue. | Cutting needle tip severs
and removes tissue into
hollow needle. Vacuum
assisted | |
| Patient contact
materials | Stainless steel; surgical-
grade plastic | Stainless steel; surgical-
grade plastic | Nitinol; Stainless steel;
surgical-grade plastic | |
| Outer sheath
adjustment | Inner tip
adjustment | Power source | Hand-held
procedure? | Single use
disposable device
vs. reusable device |
| Forceps and sheath
positioned and length
adjusted by hand | Outer sheath positioned and
length adjusted by hand.
Length locked with screw | Outer sheath positioned and
length adjusted by hand.
Length locked with screw | Yes | Single use, disposable hot
biopsy forceps and handle;
reusable electrosurgical
unit and power cord |
| Forceps tip positioned and
opened/closed with handle | Cylinder tip positioned and
length adjusted/locked with
needle stopper knob | Needle tip positioned and
length adjusted/locked with
needle stopper knob | | |
| DC electrosurgical unit
Electrical power connected
to biopsy forceps
instrument via a cord from
DC electrosurgical unit.
3V DC high frequency | DC Motor,
electromechanical driven
rotation
No electrical power
connected to instrument or
patient. Rotation is
mechanically transferred to
handle via isolated drive
cable.
110V AC | Manual | | |
| Yes | Yes | Yes | Single use, disposable
cylinder needle and handle;
reusable motor and drive
cable | Single use, disposable
biopsy needle |
6
PERFORMANCE TESTING - (NON-CLINICAL) BENCH
The EndoDrill® Model X System has been determined to be substantial equivalent to the predicate device. Side by side engineering bench testing have been performed to support substantial equivalence with the reference predicate device. These tests showed that the EndoDrill® Model X to meets applicable ISO, and FDA safety and performance standards,
Non-clinical bench performance testing completed:
- Engineering comparative testing including: ●
- o Evaluate effectiveness of
- " Advance of needle
- Retreat of stylet
- l Visibility of needle
- . Retreat of needle
- Withdrawal from endoscope
- I Repetition test
- Needle durability, including bending
- I Proper functioning of motor, drive train and controls during penetration passes through surrogate tissues
- I Ultrasound compatibility
- " Advance of needle
- o Evaluate effectiveness of
7
K212423 Page 5 of 5
- Endoscope compatibility ■
- . Locking mechanisms for outer sheath-and needle adjustment
- Tissue penetration
- I Tissue collecting
- I Tissue transport
- Tissue artefacts (heat/burning/crusch) due to rotation I
- Determine Tissue penetration force
- O Sample acquisition
- Evaluate Tissue harvesting mechanisms o
- . Over pressure method (air)
- I Fluid fluid
- . Mandril
- Transport of multiple samples
- o Compare quality of samples collected
- Engineering testing ●
O
- o Performance testing
- . Drive motor
- . Drive Cable
- . Drive motor controls
- Sterilization/Shelf Life testing ●
- Biocompatibility
- IEC 60601 Electrical safety and EMC ●
PERFORMANCE TESTING - ANIMAL
There are no animal data submitted with this Notification.
PERFORMANCE TESTING - CLINICAL
There are no clinical data submitted with this Notification.
CONCLUSION:
Based on the results of non-clinical (bench) testing, the EndoDrill® Model X System performs safely and as intended. Regarding comparison of intended use and technological characteristics, it is determined that the EndoDrill® Model X System is substantially equivalent to the predicate device.