The DANNIK Specimen Retrieval System is in surgical procedures to capture organs or tissue to be removed from the body cavity during Laparoscopic Surgery via extracorporeal manual morcellation.

The DANNIK Specimen Retrieval System is contraindicated for laparoscopic power morcellation during gynecologic procedures. The DANNIK Specimen Retrieval System is contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the judgment of the physician, use of such a device would be contrary to the best interest of the patient.

Device Description

The DANNIK Specimen Retrieval System are sterile single patient use devices, which comprise of a flexible plastic bag with and without a deployment mechanism. The bag consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. The deployment mechanism consists of a push-pull rod and an introducer assembly. The deployment mechanism allows for easy insertion through the cannula and full deployment the bag with the use of the biasing arms.

The DANNIK Specimen Retrieval System is comprised of a flexible plastic bag with and without a deployment mechanism.

The bag is made from polyurethane and/or rip-stop nylon and consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. The bags come in sizes from 50 to 3000 mL.

The deployment mechanism consists of a push-pull rod and introducer assembly. The push-pull rod consists of a handle, shaft and biasing arms and is made from a combination of Stainless Steel, Nitinol, ABS, and PC. The introducer assembly consists of a tube and is made from ABS and/or PC. The deployment mechanism allows easy insertion through the cannula and full deployment the use of the metallic biasing arms. Introducers range from 5 to 15 mm in diameter.

This device is packaged and sterilized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the DANNIK Specimen Retrieval System, based on the provided document:

This document describes a 510(k) premarket notification for a medical device. It's important to note that 510(k) clearances are for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical trials with defined acceptance criteria for disease detection/diagnosis. The "acceptance criteria" here therefore refer to the performance benchmarks against the predicate device in non-clinical settings.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Testing Against Predicate)	Reported Device Performance
Mechanical Performance:
Appropriate introduction forces (comparable to predicate device)	Testing showed that the devices met the same requirements as the predicate device.
Seam strengths (comparable to predicate device)	Testing showed that the devices met the same requirements as the predicate device.
Fluid permeability (comparable to predicate device)	Testing showed that the devices met the same requirements as the predicate device.
Open/closure forces (comparable to predicate device)	Testing showed that the devices met the same requirements as the predicate device.
General operation (comparable to predicate device)	Testing showed that the devices met the same requirements as the predicate device.
Sterilization:
Sterilization via Ethylene Oxide (EO) to achieve a Sterility Assurance Level (SAL) of $10^{-6}$ (ISO 11135:2014)	Validation of the Ethylene Oxide sterilization process was accomplished according to ISO 11135 to provide a SAL of $10^{-6}$. Validation of the Ethylene Oxide process remains unchanged from the original submission.
Packaging:
Compliance with ISO 11607 series of standards for packaging	Packaging for these devices was designed and complies with the requirements of ISO 11607 series of standards.
Biocompatibility:
Conformance to ISO 10993-1 and relevant sub-parts	Biocompatibility was evaluated in accordance with ISO 10993-1 and relevant sub-parts for the device, given the nature and duration of patient contact. (The predicate device's biocompatibility was "Unknown" in the comparison table, but the DANNIK device explicitly states conformance).

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a "sample size" for a clinical test set in the traditional sense, as this was a non-clinical bench testing submission. The testing involved comparing the DANNIK Specimen Retrieval System to the predicate device, the Espiner Tissue Retrieval System (K111845), using various bench tests.

Test Set: Non-clinical bench testing of the DANNIK Specimen Retrieval System.
Data Provenance: The testing was conducted to demonstrate substantial equivalence to a legally marketed predicate device. The document does not specify the country of origin for the data, but it is for a US FDA submission, implying the tests were conducted under US regulatory guidelines or accepted international standards. The testing is retrospective in the sense that it compares features to an already marketed device, but the actual tests on the DANNIK device would be considered part of a prospective testing plan for the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. For a 510(k) submission based on non-clinical bench testing, expert consensus for ground truth as seen in diagnostic device studies is typically not required. The "truth" for these tests is defined by established engineering standards and performance specifications for medical devices.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical ground truth established by experts requiring an adjudication method. The assessment of performance against the predicate was based on objective-bench testing parameters.

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

Not applicable. This device is a physical specimen retrieval system, not an AI or diagnostic imaging device. Therefore, no MRMC study or AI-related effectiveness analysis was performed.

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

Not applicable. This device is a physical specimen retrieval system and does not involve any algorithms or AI for standalone performance evaluation.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

Engineering specifications and performance characteristics of the DANNIK Specimen Retrieval System.
Performance data from the predicate device (Espiner Tissue Retrieval System, K111845) which served as the benchmark for demonstrating substantial equivalence.
International standards such as ISO 11135 (sterilization) and ISO 10993 (biocompatibility), and ISO 11607 (packaging).

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device and does not involve machine learning or AI, so there is no concept of a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an algorithm.

Summary

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April 21, 2020

DANNIK Olga Haberland Regulatory Compliance 941 West Morse Blvd. Suite 100 Winter Park, Florida 32789

Re: K200053

Trade/Device Name: DANNIK Specimen Retrieval System (Bag Only) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: January 6, 2020 Received: January 10, 2020

Dear Olga Haberland:

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

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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,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K200053

Device Name DANNIK Specimen Retrieval System

Indications for Use (Describe)

The DANNIK Specimen Retrieval System is in surgical procedures to capture organs or tissue to be removed from the body cavity during Laparoscopic Surgery via extracorporeal manual morcellation.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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www.dannik.us

510(K) SUMMARY

Contact Information DANNIK 941 West Morse Blvd. Suite #100 Winter Park, FL 32789 Phone: (407) 745-1698 Olga Haberland, Regulatory Compliance January 4, 2020

1. Device Name
- Trade Name - DANNIK Specimen Retrieval System
- Common Name Retrieval Bag, Specimen Retrieval Bag ●
- Regulation Number - 876.1500
- Classification Name Laparoscope, General & Plastic Surgery ●
- Product Code: GCJ
- Classification: Class II
- Classification Panel: General & Plastic Surgery
1. Substantially Equivalent Device
- Legally Marketed (Unmodified Devices): ●
  - o The Espiner Tissue Retrieval System
  - o 510(k) K111845
1. Description

1. Indications for Use
  The DANNIK Specimen Retrieval System is indicated for use in surgical procedures to capture organs or tissue to be removed from the body cavity during Laparoscopic Surgery via extracorporeal manual morcellation.

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www.dannik.us

electrosurgical and laser instruments), and when, in the judgment of the physician, use of such a device would be contrary to the best interest of the patient.



Device	The Espiner Tissue Retrieval System (K111845)	DANNIK Specimen Retrieval System
Intended Use	Endoscope and Accessories (GCJ)	SAME
Outline	Image: Espiner Tissue Retrieval System Outline	Image: DANNIK Specimen Retrieval System Outline
Design	The Espiner Tissue Retrieval System consists of a family ofimpervious sacs which are sterile single use device that can beused alone of with a dedicated introducer system for theencaptured and removal of an organ, tissue or fluid from thebody cavity during laparoscopic surgery.The sac includes introduction tab(s) or tether and a drawstring(closure suture). The introduction tab(s) are used as a contactpoints for the instrument (tether for attachment to thededicated introducer) for introduction through an appropriatelysized cannula. The drawstring facilitates a secure closure ofthe sac.The dedicated introducer comprises an introducer tube withhandle, and push rod. The introducer allows for the bag to beinserted through an appropriately sized port. The push rodassembly comprises a loop on one end and biasing arms onthe other, which allow the bag mouth to open upondeployment.	The DANNIK Specimen Retrieval System consist of a family ofretrieval bags which are sterile single-use devices that can beused alone or with a dedicated introducer system for thecapture and removal of organs or tissue from the body cavityduring laparoscopic surgery.The bag includes an introduction tab or tether and a closuresuture. The introduction tab is used as a contact point for theinstrument (tether for attachment to the introducer assembly)for introduction through an appropriately sized cannula. Thedrawstring facilitates a secure closure of the bag.The introducer assembly comprises an introducer tube withhandle, and push rod. The introducer allows for the bag to beinserted through an appropriately sized port. The push rodassembly comprises a loop on one end and biasing arms onthe other, which allow the bag mouth to open upondeployment.
Volume	50 to 6000 mL	50 to 3000 mL
Cannula Diameter	5 to 15 mm	SAME
Performance/Testing	Bench Testing to demonstrate safety and effectivenessto the predicate device.	Performance testing showed that the deviceperformed equivalent or better and is thereforesubstantially equivalent in performance to thepredicate devices
Sterilization	Sterilized using Ethylene Oxide for single patientuse	SAME
Prescription Only	Yes	SAME
Biocompatibility	Unknown	Conforms to ISO 10993

The DANNIK Specimen Retrieval System is comprised of a flexible plastic bag with and without a deployment mechanism.

This device is packaged and sterilized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.

941 West Morse Blvd. Suite 100. Winter Park, FL 32789 U.S.A. +1-407-745-1698

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www.dannik.us

There are no FDA performance standards for these products. The sterilization is performed by Ethylene Oxide per ISO 11135:2014. This device is available by Prescription Only for use in a Hospital Operating Room. This device is compliant with FDA Class II requirements for ISO 10993.

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7. Nonclinical Tests

The DANNIK Specimen Retrieval System have been determined to be substantially equivalent to the Espiner Tissue Retrieval System through performance studies and bench testing which included determining and verifying appropriate introduction forces, seam strengths, tests for fluid permeability, open/closure forces and general operation. Testing showed that the devices met the same requirements as the predicate device.

Validation of the Ethylene Oxide sterilization process was accomplished according to ISO 11135 to provide a SAL of 10-9. Validation of the Ethylene Oxide process remains unchanged from the original submission.

Packaging for these devices was designed and complies with the requirements of ISO 11607 series of standards.

Device biocompatibility was evaluated in accordance with ISO 10993-1 and relevant sub-parts for device, given the nature and duration of patient contact.

Clinical Tests 8.

There were no clinical trials performed on the DANNIK Specimen Retrieval System.

1. Conclusions
  Based on the indications for use and technological characteristics, the DANNIK Specimen Retrieval System has shown to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes 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 (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.