(102 days)
Not Found
No
The device description and intended use describe a purely mechanical system for specimen retrieval. There is no mention of any software, data processing, or analytical capabilities that would suggest the use of AI or ML.
No.
The DANNIK Specimen Retrieval System is used to capture and remove organs or tissue during surgery. It does not provide any therapeutic effect or treatment to the patient.
No
Explanation: The DANNIK Specimen Retrieval System is used to capture organs or tissue during laparoscopic surgery, not to diagnose medical conditions. Its function is to facilitate the removal of specimens from the body.
No
The device description clearly outlines physical components made of materials like plastic, stainless steel, and nitinol, indicating it is a hardware device.
Based on the provided information, the DANNIK Specimen Retrieval System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "capture organs or tissue to be removed from the body cavity during Laparoscopic Surgery." This is a surgical procedure performed on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a physical system (bag, deployment mechanism) used to physically retrieve tissue during surgery. It does not involve any reagents, assays, or analysis of biological samples for diagnostic purposes.
- Lack of Diagnostic Function: The description focuses on the mechanical function of retrieving tissue. There is no mention of analyzing the tissue for diagnostic information.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition. The DANNIK Specimen Retrieval System's function is purely for the physical removal of tissue during surgery.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital Operating Room
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)
Bench Testing to demonstrate safety and effectiveness to the predicate device.
Performance testing showed that the device performed equivalent or better and is therefore substantially equivalent in performance to the predicate devices.
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.
There were no clinical trials performed on the DANNIK Specimen Retrieval System.
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
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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.
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.
| 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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Image /page/3/Picture/1 description: The image contains the word "DANNIK" in large, blue, bold letters. Above the word is a curved line that is blue on the outside and purple on the inside. The word "DANNIK" is the main focus of the image and is easily readable.
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
-
- 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
-
- Substantially Equivalent Device
- Legally Marketed (Unmodified Devices): ●
- o The Espiner Tissue Retrieval System
- o 510(k) K111845
-
- 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.
-
- 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.
- Indications for Use
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,
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Image /page/4/Picture/1 description: The image shows the logo for DANNIK. The logo is blue and features the word "DANNIK" in large, bold letters. Above the word is a curved line that is blue on the outside and purple on the inside. The logo is simple and modern.
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.
| 6. Technological Characteristics of the Subject Device Compared to the Predicate Device | |||
|---|---|---|---|
| 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 of | ||
| impervious sacs which are sterile single use device that can be | |||
| used alone of with a dedicated introducer system for the | |||
| encaptured and removal of an organ, tissue or fluid from the | |||
| body 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 contact
points for the instrument (tether for attachment to the
dedicated introducer) for introduction through an appropriately
sized cannula. The drawstring facilitates a secure closure of
the sac.
The dedicated introducer comprises an introducer tube with
handle, and push rod. The introducer allows for the bag to be
inserted through an appropriately sized port. The push rod
assembly comprises a loop on one end and biasing arms on
the other, which allow the bag mouth to open upon
deployment. | The DANNIK Specimen Retrieval System consist of a family of
retrieval bags which are sterile single-use devices that can be
used alone or with a dedicated introducer system for the
capture and removal of organs or tissue from the body cavity
during laparoscopic surgery.
The bag includes an introduction tab or tether and a closure
suture. The introduction tab is used as a contact point for the
instrument (tether for attachment to the introducer assembly)
for introduction through an appropriately sized cannula. The
drawstring facilitates a secure closure of the bag.
The introducer assembly comprises an introducer tube with
handle, and push rod. The introducer allows for the bag to be
inserted through an appropriately sized port. The push rod
assembly comprises a loop on one end and biasing arms on
the other, which allow the bag mouth to open upon
deployment. | |
| Volume | 50 to 6000 mL | 50 to 3000 mL | |
| Cannula Diameter | 5 to 15 mm | SAME | |
| Performance/
Testing | Bench Testing to demonstrate safety and effectiveness
to the predicate device. | Performance testing showed that the device
performed equivalent or better and is therefore
substantially equivalent in performance to the
predicate devices | |
| Sterilization | Sterilized using Ethylene Oxide for single patient
use | 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.
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.
941 West Morse Blvd. Suite 100. Winter Park, FL 32789 U.S.A. +1-407-745-1698
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Image /page/5/Picture/1 description: The image shows the word "DANNIK" in a bold, blue font. Above the word is a curved blue line, with a thinner purple line just below it. The word appears to be a logo or brand name.
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.
008_1
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.
-
- 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.
- Conclusions