(372 days)
Not Found
No
The description focuses on the physical components and intended use of a laparoscopic tissue retrieval bag, with no mention of AI or ML capabilities.
No.
The device is described as a tissue retrieval bag used for collection and extraction of tissue during laparoscopic surgical procedures, not for treating a disease or condition.
No
The device is a laparoscopic tissue retrieval bag used to collect and extract tissue during surgical procedures. Its purpose is mechanical containment, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is a physical, sterile pouch bag made of polyurethane coated polyamide, intended for surgical tissue retrieval. It is a hardware device, not software.
Based on the provided information, the Mediflex device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the collection and extraction of tissue during laparoscopic surgical procedures. This is a surgical tool used in vivo (within the body) to handle tissue that has already been removed or is being removed.
- Device Description: The description details a sterile bag for tissue retrieval, not a device that analyzes biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing biological specimens.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The Mediflex device's function is purely mechanical for tissue handling during surgery.
N/A
Intended Use / Indications for Use
The Mediflex device is a laparoscopic tissue retrieval bag model 24003-MF. The sterile bag is a single use disposable device used as a receptacle for collection and extraction of tissue during laparoscopic surgical procedures.
Product codes
GCJ
Device Description
The Mediflex device model 24003-MF is for endoscopic retrieval of tissue. It consists of a sterile pouch bag wrapped in coated paper inside a Tyvek peel pouch that is a single use, disposable and durable device. The pouch bag is made of polyurethane coated polyamide. It is suitable for collection and extraction of tissue through 10, 11 or 12mm cannula during laparoscopic surgical procedures. The sterile pouch bag construction is suitable for function and made for opening and closure during the surgical retrieval process. The outer Tyvek peel pouch is marked with the device identification.
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)
The performance and safety bench testing activities were conducted on the tissue retrieval bag to establish the safety compliance is sustained for the new device. Validation and verification of compliance with the following mandatory and voluntary standards has been made to validate new production process using new vendor sources are compliant.
- · 1SO9001/GMP/ISO13485: Quality System Certification
- · ISO14971-1:2007 Risk Management
- · ISO10993-1:2009 Biocompatibility
- · ISO10993-10:1995 Sensitization Test
- · ISO10993-10:1995 Irritation / Intracutaneous Reactivity Test
- · ISO10993-5:1999 Memelution Cell Culture Cytotoxicity Test
- · ISO10993-4:2002 Hemolysis Test
- · ISO10993-11:2006 Systemic Toxicity Test
- · ISO10993-11:2006 Pyrogenicity Test
- · ISO11135-1:2007 Sterilization Validation
- · ISO11607-2:2009 Sealing and Accelerated Aging
- · ISO11737-1:2006 Bioburden Test
- · EN868-5 Annex D Sealing Strength
- · ASTM F1929-98 Dye Penetration Test
- · EN868-5 Annex E Pealing Characteristic
- · EN868-5 Annex B Resistance of Sterilization
The risk analysis shows that there are no new questions of safety and effectiveness for the Mediflex laparoscopic tissue retrieval bag model 24003-MF.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
510(K) SUMMARY - K123728 August 29, 2012
DEC 1 1 2013
SUBMITTER INFORMATION: (2424366)
Flexbar Machine Corp. (d/b/a Mediflex) 250 Gibbs Road Islandia. New York 11749 Tel: 631-582-8440 Contact: Mr. Larry Derrig
FDA AGENT/CORRESPONDING OFFICIAL INFORMATION:
North American Technical Services (NATS) Corp. 30 Northport Rd Sound Beach, NY 11789 Tel: 631-744-0059 Fax: 631-744-0192 Email: natscorp@aol.com Contact: Stephen T. Mlcoch
DEVICE NAME:
Name: Laparoscopic Tissue Retrieval Bag, Model 24003-MF Proprietary Model: 24003-MF Classification: Il Product Code: GCJ Regulation: 21 CFR 876.1500
PREDICATE DEVICES:
Vernon-Carus Limited, K033842 Models Nubert, Albert, and Hubert
DESCRIPTION:
The Mediflex device model 24003-MF is for endoscopic retrieval of tissue. It consists of a sterile pouch bag wrapped in coated paper inside a Tyvek peel pouch that is a single use, disposable and durable device. The pouch bag is made of polyurethane coated polyamide. It is suitable for collection and extraction of tissue through 10, 11 or 12mm cannula during laparoscopic surgical procedures. The sterile pouch bag construction is suitable for function and made for opening and closure during the surgical retrieval process. The outer Tyvek peel pouch is marked with the device identification.
SUBSTANCIAL EQUIVALENCE AND TECHNOLOGY:
The Mediflex laparoscopic tissue retrieval bag model 24003-MF is substantially equivalent in design, construction and materials to the identified predicate device model Nubert. They both use the same technology, function the same way and have the identical purpose. They both are the same size and open or close in an identical procedure. There is a Tyvek peel pouch that contains the coated paper over the sterile pouch bag made of polyurethane (PU) coating over nylon polyamide.
1
The difference to the predicate device is the material source vendor used for the sterile pouch bag but not the material type. Both use the same generic polyurethane (PU) coating over nylon polyamide for the sterile pouch bag. The sterilization methods differ too. EO method is used for 24003-MF and a radiation process is used for predicate model Nubert.
Sterilization by means of EO by the contract sterilizer assures a sterility assurance level of 100 . The biocompatibility evaluation has shown compliance to ISO10993-1 for the predicate device Nubert and 24003-MF. The specific test evaluations assure material source differences are compliant. Therefore, this device is as safe. It is as effective and performs equivalent to the predicate device by sustaining the same construction. The use of Tyvek peel pouch as a container for the sterile tissue pouch assures a durable and equivalent method to the validated predicate device bag container.
| CHARACTERISTICS | FLEXBAR MACHINE CORP
d/b/a MEDIFLEX 24003-MF | VERNON-CARUS LIMITED
K033842 NUBERT |
|-------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|
| STERILE | ISO11135-1 EO method
(SAL: 10-6) | Radiation process
(SAL: 10-6) |
| SIZE | Area dimension 195mm x 90mm
(see drawing Section 11) | Area dimension 195mm x 90mm |
| STERILE BAG MATERIAL | PU coated on nylon polyamide | PU coated on nylon polyamide |
| OPEN / CLOSE METHOD | Instruction
1 page Section 13 | Instruction
2 pages Section 12 |
| DISPOSAL | One ( 1 ) time use | One ( 1 ) time use |
| FUNCTION | Collection, extraction of tissue via
10mm, 11mm or 12mm cannula | Collection, extraction of tissue via
10mm, 11mm or 12mm cannula |
| BIOCOMPATIBILITY | ISO10993-1 | ISO10993-1 |
| DURABILITY/LIFE | ISO11607 / 5 year shelf
Tyvek Peel Pouch | ISO11607 / 5 year shelf |
| BODY CONTACT
TYPE/DURATION | Tissue, Blood /