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.

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: 1. A biopsy needle consisting of stainless-steel with a coring cylinder tip collecting samples in a fluid- and airtight tubing when rotated. 2. An outer sheath that surrounds the rotating needle and may be used to place the inner needle at the biopsy site. 3. 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "EndoDrill® Model X." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy and safety from scratch.

Therefore, the document does not contain the information typically associated with a study proving a device meets acceptance criteria derived from a full clinical trial or a deep learning AI model performance. Specifically, it lacks:

A table of acceptance criteria and reported device performance (in terms of clinical outcomes or diagnostic accuracy). This document focuses on demonstrating comparable characteristics to predicate devices and performance in bench testing, not clinical performance metrics.
Sample sizes for test sets where clinical performance is evaluated. The testing described is primarily engineering bench testing.
Number of experts used to establish ground truth, their qualifications, and adjudication methods. Ground truth is not established in the clinical sense in this submission.
MRMC comparative effectiveness study results or effect sizes.
Standalone (algorithm only) performance. This is a physical biopsy instrument, not an algorithm.
Type of ground truth used (pathology, outcomes data, etc.) relevant to clinical efficacy.
Sample size for training set or how ground truth for training set was established. This refers to machine learning models, not physical devices.

Instead, the document details bench testing to demonstrate the safety and fundamental performance of the device and its substantial equivalence to predicate devices.

Here's an analysis of the provided information relevant to "acceptance criteria" and "study" in the context of this 510(k) submission:

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide a table of acceptance criteria with numerical performance targets and reported values in the typical sense of a clinical diagnostic study (e.g., sensitivity, specificity thresholds). Instead, "acceptance criteria" are implied by the comprehensive list of bench engineering tests performed to ensure the device performs as intended and meets safety standards applicable to a Class II device.

The study proves the device meets (implied) acceptance criteria through:

Engineering comparative testing: Evaluating the effectiveness of needle advance/retreat, visibility, withdrawal from endoscope, repetition test, needle durability (including bending), proper functioning of motor/drive train/controls during penetration, and ultrasound compatibility.
Endoscope compatibility.
Locking mechanisms performance.
Tissue penetration and collection.
Tissue transport.
Evaluation of tissue artifacts (absence of heat/burning/crushing).
Determination of tissue penetration force.
Sample acquisition and evaluation of sample quality.
Performance testing of drive motor, drive cable, and controls.
Sterilization/Shelf Life testing.
Biocompatibility testing.
IEC 60601 Electrical safety and EMC.

The overall acceptance criterion for a 510(k) is "substantial equivalence" to a legally marketed predicate device, ensuring the new device is as safe and effective as the predicate. The performance testing listed above serves to demonstrate this.

2. Sample sized used for the test set and the data provenance:

Sample Size: Not specified for individual bench tests. Bench testing for medical devices often involves a sufficient number of units to demonstrate robust and reproducible performance, but exact sample sizes are typically detailed in the full test reports, not the public 510(k) summary. For example, "repetition test" implies multiple repetitions, and "needle durability" tests would involve multiple cycles or stress tests.
Data Provenance: The testing was "non-clinical (bench) testing" performed by the manufacturer, Bibbinstruments AB (based in Sweden, as indicated by the address: S-223 81 Lund, SWEDEN). The data is retrospective in the sense that it was generated pre-submission for regulatory clearance. No external or patient data provenance is relevant here as it's not a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable in the context of bench testing for a physical device. Ground truth as understood in diagnostic AI or clinical trials (e.g., pathological diagnosis, clinical outcomes) is not established here. The "ground truth" for these tests are engineering specifications and performance metrics related to the device's physical functions.

4. Adjudication method for the test set:

Not applicable. This is not a study requiring adjudication of expert interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is a physical biopsy instrument, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical biopsy instrument.

7. The type of ground truth used:

The "ground truth" for this submission is based on engineering specifications, verified physical properties, and functional performance metrics established through bench testing, demonstrating that the device operates as intended and is comparable to predicate devices in terms of its mechanical function (e.g., ability to penetrate tissue, collect samples, durability, electrical safety). There is no "pathology" or "outcomes data" ground truth directly presented for the device's diagnostic accuracy in a clinical setting, as this type of clearance relies on equivalence for the instrument itself.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of a physical device's regulatory submission using bench testing. This term typically refers to data used to train machine learning models.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for a machine learning model.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K212423

Device Name EndoDrill® Model X biopsy instrument

Indications for Use (Describe)

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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510(K) SUMMARY

DATE	March 24, 2023
SUBMITTER	Bibbinstruments ABMedicon VillageS-223 81 LundSWEDEN
CONTACT PERSON	Lotta LjungbergDirector QA/RA Bibbinstruments ABTel : +46 76 034 24 40Lotta.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 UseAspiration Needle, K180449Boston Scientific Radial Jaw™ 4 Single-Use HotBiopsy Forceps, K101657
INDICATIONS FOR USE:	The EndoDrill® Model X is intended to be usedwith an ultrasound endoscope for ultrasonicallyguided fine needle sampling of submucosal- andextramural lesions within gastrointestinal tract(i.e. esophagus, mediastinal masses, stomach,pancreas, liver, small- and large intestines, lymphnodes and perirectal masses). This device is fordiagnostic purposes only.

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DEVICE DESCRIPTION:

EndoDrill® Model X

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:

1. A biopsy needle consisting of stainless-steel with a coring cylinder tip collecting samples in a fluid- and airtight tubing when rotated.
1. An outer sheath that surrounds the rotating needle and may be used to place the inner needle at the biopsy site.
1. 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.

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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 biopsyforceps are specificallydesigned to collect tissueendoscopically forhistologic examination.These forceps should notbe used for any otherpurpose than the intendedfunction. These Single-UseHot Biopsy Forceps areintended to be used throughan endoscope to cauterizeand remove polyps and/ortissue specimensthroughout the alimentarytract. The alimentary tractincludes the esophagus,stomach, duodenum,jejunum, ileum and colon.	The EndoDrill® Model X isintended to be used with anultrasound endoscope forultrasonically guided fineneedle sampling ofsubmucosal- and extramurallesions withingastrointestinal tract (i.e.esophagus, mediastinalmasses, stomach, pancreas,liver, small- and largeintestines, lymph nodes andperirectal masses). Thisdevice is for diagnosticpurposes only	This instrument has beendesigned to be used with anOlympus ultrasoundendoscope for ultrasonicallyguided fine needleaspiration (FNA) and fineneedle biopsy (FNB) ofsubmucosal and extramurallesions within thegastrointestinal tract (i.e.pancreatic masses,mediastinal masses,perirectal masses and lymphnodes).
Device RegulatoryClassification	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	EndoscopyOptic/Ultrasound
Tip dimensions	2,20 mm (14 Gauge)	1,47 mm (17 Gauge)	19-25 Gauge
Method of tissuedissection	Electrically heated forcepscuts tissue	Electromechanically rotatedcylinder cuts tissue.	Manually moved beveledneedle tip cuts tissue
Method of tissuecollection	Electrically heated forcepscuts, severs and collectstissue	Electromechanically rotatedcylinder cuts, severs andcollects tissue.	Cutting needle tip seversand removes tissue intohollow needle. Vacuumassisted
Patient contactmaterials	Stainless steel; surgical-grade plastic	Stainless steel; surgical-grade plastic	Nitinol; Stainless steel;surgical-grade plastic
Outer sheathadjustment	Inner tipadjustment	Power source	Hand-heldprocedure?	Single usedisposable devicevs. reusable device
Forceps and sheathpositioned and lengthadjusted by hand	Outer sheath positioned andlength adjusted by hand.Length locked with screw	Outer sheath positioned andlength adjusted by hand.Length locked with screw	Yes	Single use, disposable hotbiopsy forceps and handle;reusable electrosurgicalunit and power cord
Forceps tip positioned andopened/closed with handle	Cylinder tip positioned andlength adjusted/locked withneedle stopper knob	Needle tip positioned andlength adjusted/locked withneedle stopper knob
DC electrosurgical unitElectrical power connectedto biopsy forcepsinstrument via a cord fromDC electrosurgical unit.3V DC high frequency	DC Motor,electromechanical drivenrotationNo electrical powerconnected to instrument orpatient. Rotation ismechanically transferred tohandle via isolated drivecable.110V AC	Manual
Yes	Yes	Yes	Single use, disposablecylinder needle and handle;reusable motor and drivecable	Single use, disposablebiopsy needle

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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

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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 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.

Regulation Number and Section

§ 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.