(79 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical performance of a tissue containment system, with no mention of AI or ML algorithms for analysis, processing, or decision-making.
No.
The device is a containment and removal system for resected tissue during surgery, not a device used to treat a disease or condition.
No
The device is described as a tissue containment system used during surgery for the isolation and containment of tissue for removal, acting as a receptacle for collection and extraction. Its function is to facilitate the surgical procedure and contain resected tissue, not to diagnose a condition or disease.
No
The device description clearly outlines physical components (More-Cell Bag, Visi-Shield) made of materials like polyurethane and metal, and the performance studies focus on physical properties and biological interactions, not software functionality.
Based on the provided information, the More-Cell-System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to contain tissue during surgery for removal, specifically to prevent the spread of tissue during power morcellation. This is a surgical containment and extraction function, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a physical system (bag and shield) designed to contain tissue within the body during a surgical procedure. It does not involve analyzing biological samples to provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze blood, tissue, or other biological samples to diagnose a disease or condition.
- Performance Studies: The performance studies focus on the physical integrity and containment capabilities of the device (impermeability, puncture resistance, material strength, usability) and its ability to prevent the spread of cells during surgery. They do not involve evaluating the device's accuracy in detecting or measuring substances in biological samples.
In summary, the More-Cell-System is a surgical device used for tissue containment and removal during laparoscopic procedures. It does not perform any in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for power morcellation and removal.
When used in women with fibroids, the More-Cell System is for women who are pre-menopausal and under age 50. More-Cell-System is compatible with electromechanical laparoscopic power morcellators that are between 12 mm and 20 mm in shaft outer diameter and between 95 mm and 170 mm in shaft working length.
Product codes (comma separated list FDA assigned to the subject device)
PMU
Device Description
The More-Cell-System device is used as a receptacle for collection and extraction of tissue during laparoscopic surgical procedures (e.g., hysterectomy and myomectomy). The key components of the device include the following:
-
A. More-Cell Bag: A single use, insufflatable, transparent, EO sterilized bag made of 50 µm thick polyurethane film that is biocompatible and cell-tight. The bag includes printed lines to aid in visualization during surgery. There are two openings to the bag: one opening that is 16 cm in diameter where a morcellator can be inserted (and where tissue can be removed), and a second opening that is 16 mm in diameter x 190 mm in length where a laparoscope can be inserted to visualize the surgical procedure. The bag capacity is 2.5 L (340 x 250 mm).
-
B. Visi-Shield: A metal sleeve with a polycarbonate window for lens protection (comes in 0° or 30° angle) that is cell-tight to protect the laparoscopic camera during a surgical procedure. Using the Visi-Shield the surgical procedure can be visualized without compromising the integrity of the bag, laparoscopic view, or safety of the laparoscopic camera.
The More-Cell-System functions in the following manner:
-
- A first incision (suprapubic) is made and a surgical port is inserted using a port obturator. The port obturator is then removed.
-
- The More-Cell Bag is introduced through the port into the abdomen.
-
- The bag is unfolded inside the abdomen and is filled with the tissue that is to undergo morcellation.
-
- The port is removed and the large opening of the bag is pulled out through the first incision where it had been introduced. The small opening of the bag is pushed through a second incision (umbilical).
-
- A trocar port is inserted into the small opening of the bag towards the encased tissue. Through this port, the More-Cell Bag is insufflated with CO2.
-
- The optic that is encased in the Visi-Shield is inserted into the umbilical trocar port.
-
- Through the large opening of the bag, a morcellator equipped with a blunt obturator is inserted towards the encased tissue. The tissue undergoes morcellation under visual control of the optic.
-
- Following completion of morcellation, the morcellator, optic (including Visi-Shield), and umbilical trocar port are removed. The small opening is closed tightly by tying two (2) knots in the neck of the bag.
-
- The More-Cell Bag is removed from the abdomen by grasping the bag at the large opening and withdrawing it through the first incision.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdomen
Indicated Patient Age Range
pre-menopausal and under age 50
Intended User / Care Setting
Surgeons (clinical use and simulated use) in a clinical environment capable of performing minimally invasive gynecologic laparoscopic surgery.
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
A simulated use study was conducted with 11 U.S. surgeons with a range of laparoscopic surgery experience (2.5 years to 30 years) to ensure that representative users can perform the critical tasks associated with the More-Cell-System and comprehend the procedural safety information. Participants were provided with the training materials, which includes a copy of the Instructions for Use and Surgery Quick Guide Instruction training videos. After review of these materials there was a one hour break. The participants then performed a simulated use on a pelvic trainer model. They were observed to assess adherence to critical tasks. Participants completed two questionnaires to assess knowledge tasks and adequacy of device usage, and participated in group interviews for comments and open feedback from users.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Testing:
- Sterilization validation: Per ANSI/AAMI/ISO 11135 and ISO 10993-7.
- Shelf life validation: For 2-years utilizing samples that have undergone accelerated aging, shipping and handling including:
- Per ASTM F1980 and ISO 11607, package integrity included visual inspection, dye penetration test, peel strength test and microbiological stability.
- Device functionality.
- Biocompatibility testing: Conducted per FDA guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"' May 1, 1995, and ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," issued September 4, 2020. Categorized as an externally communicating device, contacting tissue/bone/dentin for a limited duration
§ 884.4050 Gynecologic laparoscopic power morcellation containment system.
(a)
Identification. A gynecologic laparoscopic power morcellation containment system is a prescription device consisting of an instrument port and tissue containment method that creates a working space allowing for direct visualization during a power morcellation procedure following a laparoscopic procedure for the excision of benign gynecologic tissue that is not suspected to contain malignancy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible;
(2) Device components that are labeled sterile must be validated to a sterility assurance level of 10
−6 ;(3) Performance data must support shelf life by demonstrating continued sterility of the device or the sterile components, package integrity, and device functionality over the intended shelf life;
(4) Non-clinical performance data must demonstrate that the device meets all design specifications and performance requirements. The following performance characteristics must be tested:
(i) Demonstration of the device impermeability to tissue, cells, and fluids;
(ii) Demonstration that the device allows for the insertion and withdrawal of laparoscopic instruments while maintaining pneumoperitoneum;
(iii) Demonstration that the containment system provides adequate space to perform morcellation and adequate visualization of the laparoscopic instruments and tissue specimen relative to the external viscera;
(iv) Demonstration that intended laparoscopic instruments and morcellators do not compromise the integrity of the containment system; and
(v) Demonstration that intended users can adequately deploy the device, morcellate a specimen without compromising the integrity of the device, and remove the device without spillage of contents;
(5) Training must be developed and validated to ensure users can follow the instructions for use; and
(6) Labeling must include the following:
(i) A contraindication for use in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy;
(ii) Unless clinical performance data demonstrates that it can be removed or modified, a contraindication for removal of uterine tissue containing suspected fibroids in patients who are: Peri- or postmenopausal, or candidates for en bloc tissue removal, for example, through the vagina or via a mini-laparotomy incision;
(iii) The following boxed warning: “Warning: Information regarding the potential risks of a procedure with this device should be shared with patients. Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer. The use of this containment system has not been clinically demonstrated to reduce this risk.”
(iv) A statement limiting use of device to physicians who have completed the training program; and
(v) An expiration date or shelf life.
0
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November 10, 2021
Agency for Medical Innovations GmbH % Allison C. Komiyama, Ph.D., R.A.C. Principal Consultant AcKnowledge Regulatory Strategies, LLC 2251 San Diego Avenue, Suite B-257 San Diego, CA 92110
Re: K212659
Trade/Device Name: More-Cell-System Regulation Number: 21 CFR§ 884.4050 Regulation Name: Gynecologic Laparoscopic Power Morcellation Containment System Regulatory Class: II Product Code: PMU Dated: August 16, 2021 Received: August 23, 2021
Dear Allison C. Komiyama:
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 statutes and regulations administered by other Federal agencies.
1
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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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,
Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212659
Device Name More-Cell-System
Indications for Use (Describe)
More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for power morcellation and removal.
When used in women with fibroids, the More-Cell System is for women who are pre-menopausal and under age 50. More-Cell-System is compatible with electromechanical laparoscopic power morcellators that are between 12 mm and 20 mm in shaft outer diameter and between 95 mm and 170 mm in shaft working length.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for A.M.I. The logo is in blue and consists of the letters A, M, and I. There is a circle below each letter. The registered trademark symbol is located to the right of the last I.
510(k) Summary
DATE PREPARED
November 8, 2021
MANUFACTURER AND 510(k) OWNER
Agency for Medical Innovations GmbH Im Letten 1, 6800 Feldkirch, Vorarlberg, Austria Telephone: +43 5522 90505-4006 Fax: Official Contact: Martin Hohlrieder, Ph.D. (CTO)
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., R.A.C.; Lucie Dalet, Ph.D. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 458-9547 akomiyama@acknowledge-rs.com; Idalet@acknowledge-rs.com Email:
PROPRIETARY NAME OF SUBJECT DEVICE
More-Cell-System
COMMON NAME
Containment system, laparoscopic power morcellation, with instrument port
DEVICE CLASSIFICATION
Gynecologic laparoscopic power morcellation containment system (21 CFR 884.4050, Product Code PMU, Class II)
PREDICATE DEVICE IDENTIFICATION
| 510(k) Number | Predicate Device Name / Manufacturer |
|---|---|
| K192898 | PneumoLiner / Advanced Surgical Concepts |
The predicate device has not been subject to a design-related recall.
DEVICE DESCRIPTION
The More-Cell-System device is used as a receptacle for collection and extraction of tissue during laparoscopic surgical procedures (e.g., hysterectomy and myomectomy). The key components of the device include the following:
- A. More-Cell Bag: A single use, insufflatable, transparent, EO sterilized bag made of 50 µm thick polyurethane film that is biocompatible and cell-tight. The bag includes printed lines to aid in visualization during surgery. There are two openings to the bag: one
4
Image /page/4/Picture/1 description: The image shows the logo for A.M.I. The letters are in blue and are large and bold. There are three gray dots underneath the letters, one under each letter. There is a registered trademark symbol next to the I.
opening that is 16 cm in diameter where a morcellator can be inserted (and where tissue can be removed), and a second opening that is 16 mm in diameter x 190 mm in length where a laparoscope can be inserted to visualize the surgical procedure. The bag capacity is 2.5 L (340 x 250 mm).
-
B. Visi-Shield: A metal sleeve with a polycarbonate window for lens protection (comes in 0° or 30° angle) that is cell-tight to protect the laparoscopic camera during a surgical procedure. Using the Visi-Shield the surgical procedure can be visualized without compromising the integrity of the bag, laparoscopic view, or safety of the laparoscopic camera.
The More-Cell-System functions in the following manner: -
- A first incision (suprapubic) is made and a surgical port is inserted using a port obturator. The port obturator is then removed.
-
- The More-Cell Bag is introduced through the port into the abdomen.
-
- The bag is unfolded inside the abdomen and is filled with the tissue that is to undergo morcellation.
-
- The port is removed and the large opening of the bag is pulled out through the first incision where it had been introduced. The small opening of the bag is pushed through a second incision (umbilical).
-
- A trocar port is inserted into the small opening of the bag towards the encased tissue. Through this port, the More-Cell Bag is insufflated with CO2.
-
- The optic that is encased in the Visi-Shield is inserted into the umbilical trocar port.
-
- Through the large opening of the bag, a morcellator equipped with a blunt obturator is inserted towards the encased tissue. The tissue undergoes morcellation under visual control of the optic.
-
- Following completion of morcellation, the morcellator, optic (including Visi-Shield), and umbilical trocar port are removed. The small opening is closed tightly by tying two (2) knots in the neck of the bag.
-
- The More-Cell Bag is removed from the abdomen by grasping the bag at the large opening and withdrawing it through the first incision.
INDICATIONS FOR USE
More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for power morcellation and removal. When used in women with fibroids, the More-Cell System is for women who are premenopausal and under age 50.
More-Cell-System is compatible with electromechanical laparoscopic power morcellators that are between 12 mm and 20 mm in shaft outer diameter and between 95 mm and 170 mm in shaft working length.
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Image /page/5/Picture/1 description: The image shows the logo for A.M.I. The logo is in blue and consists of the letters A, M, and I. There are gray dots below each of the letters. There is a registered trademark symbol next to the I.
COMPARISON OF INDICATIONS FOR USE
The predicate device includes the following indications for use:
The PneumoLiner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue, considered benign, resected during single-port or multiport laparoscopic surgery during power morcellation and removal. When used in women with fibroids, the PneumoLiner is for women who are pre-menopausal and under age 50. The PneumoLiner is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15mm and 18 mm in shaft outer diameter and 135mm and 180mm in shaft working length and which have an external component that allows for the proper orienation of the laparoscope to perform a contained morcellation.
The More-Cell-System indications for use differs from the predicate with respect to multi-site versus single-port surgery and the identification of compatible laparoscopic power morcellators. These differences in indications for use are based on the differences in design of the devices and the testing provided. More-Cell-System is intended for use during multi-site laparoscopic surgeries as it includes a second opening for optic insertion. This difference does not represent a new intended use as both devices are tissue containment systems to be used during minimally invasive gynecologic laparoscopic surgery. More-Cell-System is compatible with electromechanical laparoscopic power morcellators that are between 12 mm and 20 mm in shaft outer diameter and between 95 mm and 170 mm in shaft working length. The predicate is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15 mm and 18 mm in shaft outer diameter and 135 mm and 180 mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation. These differences do not represent a new intended use.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The subject device has a similar design and dimensions and uses similar or identical materials as the device cleared in K192898. Unlike the predicate device, the More-Cell Bag has two openings to the bag: one opening where a morcellator can be inserted into the abdomen and where tissue can be removed, and a second opening where a laparoscope can be inserted to visualize the surgical procedure. A disposable laparoscopic camera sleeve called the Visi-Shield is used on the laparoscope in order to protect it against any cell contamination during the surgical procedure. The subject device has a lined pattern printed on the bag while the predicate has a grid pattern. After the tissue is removed from the abdomen, the outer part of the second opening is everted and knotted. This technique is intended to keep any residual contamination during the morcellation process from being introduced to the abdominal cavity during bag removal. The subject device is provided sterile using EO sterilization and has a shelf life of 2 years, whereas the predicate device is gamma irradiated and has a shelf life of 3 year.
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| General Device
Characteristics | Subject Device
K212659 | Predicate Device
K1928998 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Design | Tissue retrieval pouch with two
openings: large opening for
morcellator and small side
opening for laparoscope | Tissue retrieval pouch with
single opening with boot
assembly for insertion of
morcellator and laparoscope |
| Size/Capacity | Length: 340 mm
Width: 250 mm
Volume: 2.5 L | Length: 499.50 mm
Width: 350 mm
Volume: 10.58 L |
| Opening Dimensions | 16 cm diameter (large opening) | 16 cm diameter |
| | 16 mm diameter (small
opening) | |
| Bag removal method | Small opening knotted, pulled
into the abdomen and entire
bag removed through umbilical
incision | Bag removed through umbilical
incision |
| Insufflation required | Yes | Yes |
| Bag Materials | Polyurethane bag with
polyester thread, stainless steel
bracket/rivet, silicone and ink | Polyurethane bag with nylon
tether/tabs, nitinol opening ring
and ink |
| Optic Sleeve | Yes (Visi-Shield) | No |
| Optic Sleeve Materials | Stainless steel, polycarbonate
and silicone | N/A |
| LPM Compatibility | Electromechanical LPMs of
specific dimensions | Bipolar and electromechanical
LPMs of specific dimensions |
| Sterility | EtO | Gamma Radiation |
| Packaging | Tyvek pouch | Tyvek pouch |
| Shelf Life | 2 yrs | 3 yrs |
The differences between the subject and predicate devices do not raise different questions of safety and effectiveness.
SUMMARY OF NON-CLINICAL TESTING
The following non-clinical testing has been performed on the More-Cell-System to demonstrate substantial equivalence to the predicate devices:
- Sterilization validation per ANSI/AAMI/ISO 11135 and ISO 10993-7 .
- Shelf life validation for 2-years utilizing samples that have undergone accelerated aging, . shipping and handling including:
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Image /page/7/Picture/1 description: The image shows the logo for A.M.I. The logo is in blue and consists of the letters A, M, and I. There is a circle below each letter. There is a registered trademark symbol to the right of the letter I.
- Per ASTM F1980 and ISO 11607, package integrity included visual inspection, dye O penetration test, peel strength test and microbiological stability
- O Device functionality
- Biocompatibility testing:
The biocompatibility evaluation for the More-Cell-System was conducted in accordance with the FDA biocompatibility guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," issued September 4, 2020. The More-Cell-System is categorized as an externally communicating device, contacting tissue/bone/dentin for a limited duration