(27 days)
Not Found
No
The device description and performance studies focus on mechanical function and material properties, with no mention of AI or ML.
No.
The device is used for collecting and extracting tissue and organs during surgery, not for treating or curing a medical condition.
No
The device is described as a receptacle for the collection and extraction of tissue, organs, and calculi during general and laparoscopic surgery. Its purpose is to retrieve specimens, not to diagnose conditions.
No
The device description clearly outlines physical components like a flexible plastic bag, deployment mechanism, push-pull rod, and introducer assembly. It also mentions sterilization and biocompatibility testing, which are relevant to physical devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the collection and extraction of tissue, organs, and calculi during surgery. This is a surgical tool used in vivo (within the body) to retrieve specimens.
- Device Description: The description details a physical device (bag, deployment mechanism) used for physical retrieval.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide diagnostic information. IVDs typically involve reagents, assays, or analysis of biological samples to determine the presence of diseases, conditions, or markers.
This device is clearly a surgical instrument for specimen retrieval, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval Devices are indicated for use as a receptacle for the collection and extraction of tissue, organs, and calculi during general and laparoscopic surgery.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System are sterile single patient use devices, which comprise of a flexible plastic bag with a deployment mechanism. The bag is supplied pre-loaded in the introducer assembly 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 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 of the bag with the use of the biasing arms.
These devices include a handle attached to an introducer shaft with the specimen bag pre-loaded inside designed to fit down standard 5 to 15mm trocar sheaths. Advancing the push rod deploys the bag from the stored position into the operating field. Metal arms secured to the distal end of the push rod automatically open the mouth of the bag upon deployment providing a large easily accessible opening to capture the tissue. Retracting the push rod removes the arms and simultaneously cinches the closure suture to fully close the mouth of the bag.
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
Professional Healthcare Facility (Surgical Room or Operating theatre)
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
Nonclinical testing has been conducted to verify that these devices met all design specifications and are substantially equivalent to the predicate device. Testing included the following:
- Biocompatibility Testing performed in accordance with the following:
- ISO 10993-1: 2018 Biological evaluation of medical devices -Part 1: Evaluation and O testing within a risk management process (Recognition No. 2-258)
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro O cytotoxicity (Recognition No. 2-245)
- ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide O sterilization residuals (Recognition No. 14-408)
- ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin O sensitization (Recognition No. 2-296)
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for O systemic toxicity (Recognition No. 2-255)
- ISO 10993-23:2021 Biological evaluation of medical devices Part 10: Tests for irritation (Recognition No. 2-291)
- Aging Study
- Ethylene Oxide Sterilization Validation per ISO 11135:2014 Sterilization of health-care ● products - Ethylene Oxide (Recognition No. 14-529)
In addition, these devices have been compared to the predicate device through various performance studies designed to test the general device operation and bag opening, volume, integrity and seam strength.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing has been conducted to verify that these devices met all design specifications and are substantially equivalent to the predicate device.
There were no clinical trials performed on these devices.
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.
0
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.
March 12, 2025
Dannik, LLC Olga Haberland President 941 W Morse Blvd. Suite 100 Winter Park, FL 32789
Re: K250411
Trade/Device Name: DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: February 13, 2025 Received: February 14, 2025
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
2
Sincerely,
James H. Digitally signed by James H. James H. James H. James H. Jang -S Date: 2025.03.12 Jang -S 22:31:22 -04'00'
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 Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System
Indications for Use (Describe)
| The DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval Devices are indicated for use as a |
|---|
| receptacle for the collection and extraction of tissue, organs, and calculi during general and |
| laparoscopic surgery. |
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."
4
Image /page/4/Picture/1 description: The image is a logo for "DANNIK". The word "DANNIK" is written in large, bold, blue letters. Above the word is a curved line that is blue on the outside and purple on the inside. To the right of the word is a small circle with an "R" inside, indicating that the logo is a registered trademark.
510(k) TBD 510(k) SUMMARY
1. SUBMITTER'S CONTACT INFORMATION
Company: DANNIK, LLC Address: 941 West Morse Blvd. Suite #100 Winter Park, FL 32789 Contact Person: Olga Haberland, President Phone: (407) 745-1698
2. DEVICE NAME
Trade Name - DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System Common Name - Retrieval Bag, Specimen Retrieval Bag Requlation Number - 21 CFR 876.1500 Classification Name - Laparoscope, General & Plastic Surgery Product Code - GCJ Device Classification - Class II Classification Panel - General and Plastic Surgery
3. PREDICATE DEVICE
The DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval Devices claim Substantial Equivalence to the Unimax Specimen Retrieval System cleared under 510(k) K103510.
4. DEVICE DESCRIPTION
The DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System are sterile single patient use devices, which comprise of a flexible plastic bag with a deployment mechanism. The bag is supplied pre-loaded in the introducer assembly 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 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 of the bag with the use of the biasing arms.
5. INDICATIONS FOR USE
The DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval Devices are indicated for use as a receptacle for the collection and extraction of tissue, organs, and calculi during general and laparoscopic surgery.
5
Image /page/5/Picture/0 description: The image shows the logo for "DANNIK". The logo features a blue curved line above the text, with a thinner purple line running parallel to it. The text "DANNIK" is written in a bold, blue sans-serif font, with a registered trademark symbol to the right of the "K".
SUBSTANTIAL EQUIVALENCE TABLE
| Category | Subject Device | Primary Predicate |
|---|---|---|
| Device | DANNIK® Laparoscopic Single-Use Poly Specimen | |
| Retrieval System (510(k) TBD) | Unimax Specimen Retrieval System (510(k) | |
| K103510) | ||
| Intended Use | The DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval | |
| Systems are intended to be used as a receptacle for the collection | ||
| and extraction of tissue, organs, and calculi during general and | ||
| laparoscopic surgery. | The Unimax Specimen Retrieval Systems are intended to be used | |
| as a receptacle for the collection and extraction of tissue, organs, | ||
| and calculi during general and laparoscopic surgery. | ||
| Product Picture | Image: DANNIK Laparoscopic Single-Use Poly Specimen Retrieval System | |
| Introducer Shaft | ||
| Handle | ||
| Push Rod | ||
| Specimen Bag | Image: Unimax Specimen Retrieval System | |
| Introducer Shaft | ||
| Handle | ||
| Push Rod | ||
| Specimen Bag | ||
| Design | These devices include a handle attached to an introducer shaft | |
| with the specimen bag pre-loaded inside designed to fit down | ||
| standard 5 to 15mm trocar sheaths. Advancing the push rod | ||
| deploys the bag from the stored position into the operating field. | ||
| Metal arms secured to the distal end of the push rod automatically | ||
| open the mouth of the bag upon deployment providing a large | ||
| easily accessible opening to capture the tissue. Retracting the | ||
| push rod removes the arms and simultaneously cinches the | ||
| closure suture to fully close the mouth of the bag. | Same | |
| Bag Volume | 120 to 1500 mL | Same |
| Introducer | ||
| Diameter | 5, 10 and 12mm | Same |
| Biocompatibility | Conforms to ISO 10993 | Unknown |
| Sterilization | Sterilized using Ethylene Oxide for single patient | |
| use in accordance with ISO 11135 to an SAL of 10^- |
-
| Sterilized using Ethylene Oxide |
| Prescription
Use | Yes | Yes |
| Intended
Environment | Professional Healthcare Facility (Surgical Room or
Operating theatre) | Same |
7. NONCLINICAL TESTS
Nonclinical testing has been conducted to verify that these devices met all design specifications and are substantially equivalent to the predicate device. Testing included the following:
- . Biocompatibility Testing performed in accordance with the following:
- ISO 10993-1: 2018 Biological evaluation of medical devices -Part 1: Evaluation and O testing within a risk management process (Recognition No. 2-258)
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro O cytotoxicity (Recognition No. 2-245)
- ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide O sterilization residuals (Recognition No. 14-408)
- ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin O sensitization (Recognition No. 2-296)
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for O systemic toxicity (Recognition No. 2-255)
6
Image /page/6/Picture/1 description: The image shows the word "DANNIK" in large, blue, sans-serif font. Above the word is a curved line that is blue on the outside and purple on the inside. To the right of the word is a small, superscripted "R" in a circle, indicating that the word is a registered trademark.
- ISO 10993-23:2021 Biological evaluation of medical devices Part 10: Tests for irritation (Recognition No. 2-291)
- Aging Study
- Ethylene Oxide Sterilization Validation per ISO 11135:2014 Sterilization of health-care ● products - Ethylene Oxide (Recognition No. 14-529)
In addition, these devices have been compared to the predicate device through various performance studies designed to test the general device operation and bag opening, volume, integrity and seam strength.
8. CLINICAL TESTS
There were no clinical trials performed on these devices.
9. CONCLUSIONS
The subject device has equivalent indications for use as the predicate device. There are no new technologies being added to this device from the predicate, in terms of finished device functions. The device has the same intended use and application as the predicate device.