(24 days)
No
The device description details a mechanical system for tissue containment and extraction during surgery. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The 510(k) is for a label change, further suggesting no technological changes involving AI/ML.
No
The device is described as a "contained extraction system" used to isolate tissue during or prior to surgical removal, not to treat a medical condition.
No
The device is described as a "contained extraction system" used to "contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation." Its function is containment and removal of tissue, not diagnosis.
No
The device description clearly outlines physical components such as a bag, rings, tether, introducer, and plunger, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "contain and isolate tissue during, or prior to, surgical removal and /or extracorporeal manual morcellation." This describes a surgical tool used during a procedure to handle tissue, not a device used to test samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a physical system for containing and manipulating tissue during surgery (bag, ring, guard, etc.). It does not mention any components or processes related to analyzing biological samples for diagnostic purposes.
- Classification Regulation: The device is proposed under classification regulation 21 CFR 876.1500, which is for "Manual surgical instrument for gynecological laparoscopic surgery." This regulation falls under the category of surgical instruments, not IVD devices.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples in vitro)
- Detecting or measuring analytes
- Providing diagnostic information about a patient's health status
- Reagents or test kits
The Guardenia is clearly a surgical device designed to assist in the physical handling of tissue during a surgical procedure.
N/A
Intended Use / Indications for Use
The Guardenia contained extraction system is indicated to contain and isolate tissue during, or prior to, surgical removal and /or extracorporeal manual morcellation.
Contraindications:
Guardeniais contraindicated for use with laparoscopic power morcellators.
Guardenia 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
GCJ
Device Description
The Advanced Surgical Concepts Ltd, Guardenia, is a contained extraction system; proposed under classification regulation 21 CFR 876.1500, device class II and product code GCJ.
The device is provided sterile for single use.
Guardenia consists of a flexible specimen containment/extraction Bag, with an integrated Opening Ring and Bag Tether with a separate Guard component to protect the Bag and incision during morcellation with a scalpel.
The Bag is made from polyurethane (PU) film and comes preloaded in an Introducer. There is a Plunger to deploy the Bag into the abdominal cavity. Any standard sized 12mm trocar cleared to market by the FDA may be used as an accessory for device deployment. A blue arrow on the Introducer provides the user with an indicator of the correct orientation during deployment in the abdominal cavity to ensure the Bag is correctly deployed.
After the Bag is ejected from the Introducer into the abdominal cavity, the nitinol wire Opening Ring recovers its shape, opening the mouth of the Bag. This facilitates the encapsulation of the specimen. When the specimen is encapsulated, the Bag Tether, which extends externally through the trocar after deployment, is pulled, pulling the Opening Ring out through the trocar. This action also closes the mouth of the Bag inside the abdomen.
The incision is then increased to the required size (2.5-6 cm) prior to removal of the trocar is removed, the mouth of the Bag is exteriorized, and then opened outside the abdomen. If the specimen is small enough, the Bag and specimen can be removed at this stage without the need for morcellation or the use of the Guard.
If the specimen requires reduction, the Guard must be deployed first.
To deploy the Guard, the free end of the end opposite to the blue Guard Ring) is inserted through the mouth of the Bag. The yellow Anchor Ring is then inserted through the center of the Guard is actuated by flipping the Rolling Ring inward, until the incision is maximized. The Guard Petals, which are made from a tough polyethylene (PE) film, overlap, and conform to the incision, protecting the incision & Bag from damage due to inadvertent scalpel strikes or the traumatic graspers that are used to grasp and hold the tissue specimen at the incision.
The physician then performs extracorporeal manual morcellation using a grasper and a scalpel. When the tissue specimen has been removed or sufficiently reduced, the surgeon flips the opposite direction two or three times and pulls on the Removal Ribbon to remove the Guard. The Bag is removed by grasping the Opening Ring and carefully removing the Bag from the incision.
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
This Special 510(k) is for a label change only. There is no non-clinical tests required to support the change.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it. The full name reads "U.S. Food & Drug Administration".
September 29, 2023
Advanced Surgical Concepts Edward Hyland Director of Quality & Regulatory Unit 4, Sunnybank Center Upper Dargle Road Bray, WK A98 E339 Ireland
Re: K232701
Trade/Device Name: Guardenia (GAR-1) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: August 30, 2023 Received: September 5, 2023
Dear Edward Hyland:
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.
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).
Sincerely.
Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.09.29
14:29:15 -04'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
K232701
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Submission Number (if known)
Device Name
Guardenia (GAR-1)
Indications for Use (Describe)
The Guardenia contained extraction system is indicated to contain and isolate tissue during, or prior to, surgical removal and /or extracorporeal manual morcellation.
Contraindications:
Guardeniais contraindicated for use with laparoscopic power morcellators.
Guardenia 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)
The-Counter Use (21 CFR 801 Subpart C)
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Expiration Date: 06/30/2023 See PRA Statement below.
Form Approved: OMB No. 0910-0120
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| K232701 | Page 1 of 2 | |||
|---|---|---|---|---|
| 510(k) Summary | Prepared on: 2023-09-25 | |||
| Contact Details | 21 CFR 807.92(a)(1) | |||
| Applicant Name | Advanced Surgical Concepts | |||
| Applicant Address | Unit 4 Sunnybank Center, Upper Dargle Road Bray WK A98 E339 Ireland | |||
| Applicant Contact Telephone | +35312864777 | |||
| Applicant Contact | Mr. Edward Hyland | |||
| Applicant Contact Email | Ed@advancedsurgical.ie | |||
| Device Name | 21 CFR 807.92(a)(2) | |||
| Device Trade Name | Guardenia (GAR-1) | |||
| Common Name | Tissue Bag | |||
| Classification Name | Accessory to endoscope | |||
| Regulation Number | 21 CFR 876.1500 | |||
| Product Code | GCJ | |||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | ||
| K211234 | RedEx | GCJ | ||
| K211043 | Alexis CES | GCJ | ||
| Device Description Summary | 21 CFR 807.92(a)(4) | |||
| Device Description Summary | ||||
| The Advanced Surgical Concepts Ltd, Guardenia, is a contained extraction system; proposed under classification regulation 21 CFR 876.1500, device class II and product code GCJ. | ||||
| The device is provided sterile for single use. | ||||
| Guardenia consists of a flexible specimen containment/extraction Bag, with an integrated Opening Ring and Bag Tether with a separate Guard component to protect the Bag and incision during morcellation with a scalpel. | ||||
| The Bag is made from polyurethane (PU) film and comes preloaded in an Introducer. There is a Plunger to deploy the Bag into the abdominal cavity. Any standard sized 12mm trocar cleared to market by the FDA may be used as an accessory for device deployment. A blue arrow on the Introducer provides the user with an indicator of the correct orientation during deployment in the abdominal cavity to ensure the Bag is correctly deployed. | ||||
| After the Bag is ejected from the Introducer into the abdominal cavity, the nitinol wire Opening Ring recovers its shape, opening the mouth of the Bag. This facilitates the encapsulation of the specimen. When the specimen is encapsulated, the Bag Tether, which extends externally through the trocar after deployment, is pulled, pulling the Opening Ring out through the trocar. This action also closes the mouth of the Bag inside the abdomen. |
The incision is then increased to the required size (2.5-6 cm) prior to removal of the trocar is removed, the mouth of the Bag is
5
Page 2 of 2
exteriorized, and then opened outside the abdomen. If the specimen is small enough, the Bag and specimen can be removed at this stage without the need for morcellation or the use of the Guard.
If the specimen requires reduction, the Guard must be deployed first.
To deploy the Guard, the free end of the end opposite to the blue Guard Ring) is inserted through the mouth of the Bag. The yellow Anchor Ring is then inserted through the center of the Guard is actuated by flipping the Rolling Ring inward, until the incision is maximized. The Guard Petals, which are made from a tough polyethylene (PE) film, overlap, and conform to the incision, protecting the incision & Bag from damage due to inadvertent scalpel strikes or the traumatic graspers that are used to grasp and hold the tissue specimen at the incision.
The physician then performs extracorporeal manual morcellation using a grasper and a scalpel. When the tissue specimen has been removed or sufficiently reduced, the surgeon flips the opposite direction two or three times and pulls on the Removal Ribbon to remove the Guard. The Bag is removed by grasping the Opening Ring and carefully removing the Bag from the incision.
Intended Use/Indications for Use
The Guardenia contained extraction system is indicated to contain and isolate tissue during, or prior to, surgical removal and /or extracorporeal manual morcellation.
Contraindications:
Guardeniais contraindicated for use with laparoscopic power morcellators.
Guardenia 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.
Indications for Use Comparison
The Guardenia device and its predicate the Redex device have indications for use and intended use. The change and subject of the special 510k notice is to remove a contraindication, "Do not use on tissue that is known or suspected to contain malignancy." The proposed change to the contraindications, precautions of the IFU is in keeping with the indications for use and intended use of the device. The contraindication was inappropriate in that it prevented the device from being used as an containment/ extraction bag for malignant tissue even when in the physician's judgment, the use of the device would be in the patient's best interest. A precaution was added to ensure the physician is informed of the risk of occult uterine cancer. "Use caution when using the Guardenia contained extraction system for removal/manual morcellation of uterine tissue may contain unsuspected cancer." The language for the precaution is taken directly from the reference device the Applied Mexis CES device K211043. Furthermore, the reference device has no contraindication for malignant tissue.
Technological Comparison
There is no change to the physical device between the RedEx device. Therefore the technological characteristics and principles of operation are identical. Thus, Guardenia is substantially equivalent.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
This Special 510(k) is for a label change only. There is no non-clinical tests required to support the change.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)