(700 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No.
This device is designed for closing wounds after laparoscopic surgery, which is a structural approximation of tissues, not a direct treatment or prevention of a disease or condition.
No
The device is described as an Automatic Trocar Closure (ATC) device intended for approximation of tissues and percutaneous suturing of port-site fascia wounds following laparoscopic surgery. Its purpose is to close wounds, not to diagnose conditions.
No
The device description clearly outlines physical components like the Mediclose™ Device, Mediclose™ Adaptors, suture, and needles, indicating it is a hardware-based medical device.
Based on the provided information, the Mediclose™ System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "approximation of tissues and percutaneous suturing of port-site fascia wounds following laparoscopic surgery." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details a mechanical device used to pass a suture through tissue. It does not involve the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information.
IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose diseases, monitor health, or determine compatibility. The Mediclose™ System is a surgical tool used for closing wounds.
N/A
Intended Use / Indications for Use
The MedicloseTM System is a single-use indicated for approximation of tissues and percutaneous suturing of port-site fascia wounds following laparoscopic surgery.
The Mediclose™ System is a single-use suturing device indicated for approximation of tissues and percutaneous suturing of port-site fascia wounds following laparoscopic surgery.
Product codes
OCW, GCJ, HCF
Device Description
The Mediclose™ System is an Automatic Trocar Closure (ATC) device supplied with one or more Mediclose™ Adaptors, supplied sterile for single use. The combination of the Mediclose™ Device and one Mediclose™ Adaptor results in a minimally invasive surgical system which aids surgeons in closing trocar wounds following a laparoscopic procedure. In laparoscopic surgery, trocars are used to gain access to the body in a minimally invasive way. This means that these procedures are performed through incisions of approximately 12 mm, compared to traditional open surgery which needs a large wound across the abdomen. The Mediclose™ Device is available in one size and configuration, designed for single-handed use, to which each of three Mediclose™ Adaptors can be fitted, at the user's option, depending on the make/model of trocar being used.
The Mediclose™ System is intended to pass a suture through the soft-tissue laver (fascia) of a trocar wound after laparoscopic surgery. This is done with the end-goal of closing the trocar-induced wound by pulling needles through the fascia and subsequently closing the wound.
The Mediclose™ System has two items:
- The Mediclose™ Device, which incorporates the suture and needle set; .
- The Mediclose™ Adaptor, three color-coded models are available separately from the Mediclose™ . Device which are compatible with a specific brand/model of 12 mm trocar sleeves that are legally cleared for marketing in the USA, viz:
- o Ethicon EndoPath
- Covidien VersaOne o
- Applied Medical Kii o
The Mediclose™ Device also contains a needle-suture set manufactured by Assut Europe composed of two straight cylindrical needles attached to Glicofil Lac, a braided, coated, violet PGLA absorbable suture. The suture and needles are mounted into the device at the time of manufacture, making it ready to use upon opening the packaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
port-site fascia wounds
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room, sterile field
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)
Non-clinical testing of the Mediclose™ System includes:
- Sterilization validation: using ISO 11135:2020 1, 5 samples were tested and passed with acceptance criteria of sterile after half ETO cycle.
- Shelf life validation: using ISO 11607-2:2006 2;
- Transportation test: using ISTA 3A:2018 3, 1 sample was tested and passed with acceptance criteria of packaging being fully functional and undamaged.
- Sterile pack seal integrity: using ASTM F1929-15 4, 3 samples after ISTA 3A test were tested and passed with no dye penetration.
- Sterile pack seal strength: using EN 868-5:2019 5, 24 samples after ISTA 3A test were tested and passed with >1.5 N/15mm.
- Suture needle/thread strength: using USP 6, 5 samples after ISTA 3A test were tested and passed with average >14.7 N and single result >4.41 N.
- Suture knot pull strength: using USP , 10 samples after ISTA 3A test were tested and passed with average >38.2 N.
- Biocompatibility:
- Cytotoxicity: using ISO 10993-5:2009 7, optical density was measured and passed with ≥70% of the control mean % viability.
- Sensitization: using ISO 10993-10:2010 8, Kligman maximization on 35 guinea pigs was performed and passed with positive response in 0.5 degC.
- LAL bacterial endotoxicity: using EP 01/2018: 20614 10, 3 samples were tested and passed with 15 N.
- Mediclose folding part to handle tensile: using Internal test protocol, 2 samples were tested and passed with >30 N.
- Mediclose folding part to handle compression: using Internal test protocol, 3 samples were tested and passed with >30 N.
- Needle retention force: using Internal test protocol, 5 samples average were tested and passed with >15 N 30 N.
- Adaptor security tensile: using Internal test protocol, 3 samples per adaptor type were tested and passed with >30 N.
- Operating button spring resistance: using Internal test protocol, 3 samples were tested and passed with
§ 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). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
August 31, 2023
Health Value Creation BV, trading as Corporis Medical % Roger Gray VP Quality and Regulatory Donawa Lifescience Consluting Srl Piazza Albania 10 Rome. 00153 Italy
Re: K213271
Trade/Device Name: MedicloseTM System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCW, GCJ, HCF Dated: June 15, 2023 Received: June 16, 2023
Dear Roger Gray:
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,
David Krause -S
David Krause, Ph.D. Deputy Director OHT4, Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health U.S. Food and Drug Administration
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Mediclose™ System
Indications for Use (Describe)
The Mediclose114 System is a single-use indicated for approximation of tissues and percutaneous suturing of port-site fascia wounds following laparoscopic surgery.
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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3
510(k) Summary
| 510(k) Reference: | K213271 |
|---|---|
| Device Name: | Mediclose™ System |
| Type of 510(k) submission: | Traditional |
| Date of submission: | 26 August 2023 |
| 510(k) Owner and Submitter: | Health Value Creation BV, trading as Corporis Medica |
| Oxfordlaan 55 | |
| 6229 EV Maastricht | |
| The Netherlands | |
| Owner/Operator Reg. Number: | Not yet registered |
| 510(k) Application Correspondent: | Mr Roger Gray |
| VP Quality and Regulatory | |
| Donawa Lifescience Consulting | |
| Piazza Albania 10 | |
| 00153 Rome, Italy | |
| Phone: | |
| Email: | +39 06 578 2665 |
| rgray@donawa.com | |
| FDA Product Code: | OCW, GCJ, HCF |
| FDA Regulation Number: | 21 CFR 876.1500 |
| FDA Classification Name: | Endoscopic Tissue Approximation Device |
| Classification Panel: | Gastroenterology and Urology |
| Common Name: | Endoscopic Tissue Approximation Device |
| FDA Classification: | Class II |
| Submission Type: | 510(k) |
Predicate Device:
The predicate device selected for comparison with the Mediclose™ is:
| Predicate Device: | WECK EFX Endo Fascial Closure System |
|---|---|
| Sponsor: | Teleflex Medical, Inc. |
| 510(k) Number: | K132362 |
| Clearance Date: | 8 October 2013 |
| FDA Product Code: | OCW, GCJ, HCF |
| Classification Name: | Endoscopic tissue approximation device |
| Regulation No: | 21 CFR 876.1500 |
| Class: | II |
Device Description:
The Mediclose™ System is an Automatic Trocar Closure (ATC) device supplied with one or more Mediclose™ Adaptors, supplied sterile for single use. The combination of the Mediclose™ Device and one Mediclose™ Adaptor results in a minimally invasive surgical system which aids surgeons in closing trocar wounds following a laparoscopic procedure. In laparoscopic surgery, trocars are used to gain access to the body in a minimally invasive way. This means that these procedures are performed through incisions of approximately 12 mm, compared to traditional open surgery which needs a large wound across the abdomen. The Mediclose™ Device is available in one size and configuration, designed for single-handed use, to which each of three Mediclose™ Adaptors can be fitted, at the user's option, depending on the make/model of trocar being used.
4
The Mediclose™ System is intended to pass a suture through the soft-tissue laver (fascia) of a trocar wound after laparoscopic surgery. This is done with the end-goal of closing the trocar-induced wound by pulling needles through the fascia and subsequently closing the wound.
The Mediclose™ System has two items:
- The Mediclose™ Device, which incorporates the suture and needle set; .
- The Mediclose™ Adaptor, three color-coded models are available separately from the Mediclose™ . Device which are compatible with a specific brand/model of 12 mm trocar sleeves that are legally cleared for marketing in the USA, viz:
- o Ethicon EndoPath
- Covidien VersaOne o
- Applied Medical Kii o
The Mediclose™ Device also contains a needle-suture set manufactured by Assut Europe composed of two straight cylindrical needles attached to Glicofil Lac, a braided, coated, violet PGLA absorbable suture. The suture and needles are mounted into the device at the time of manufacture, making it ready to use upon opening the packaging.
Indications for Use:
The Mediclose™ System is a single-use suturing device indicated for approximation of tissues and percutaneous suturing of port-site fascia wounds following laparoscopic surgery.
Comparison of Technological Characteristics Between the Subject Device and Predicate Device:
The following table provides a comparison of the technological characteristics of the subject device and selected predicate device.
| Comparison of Technological Characteristics | |||||
|---|---|---|---|---|---|
| Characteristic | Subject device | Predicate device | Similarity | ||
| Device name | Mediclose™ System | WECK EFX | N/A | ||
| 510(k) Sponsor | Health Value Creation BV, trading as | ||||
| Corporis Medical, Netherlands | Teleflex Medical, Inc., USA | N/A | |||
| 510(k) Reference | K213271 | K132362 | N/A | ||
| Clearance Date | This submission | 8 October 2016 | N/A | ||
| FDA Product | |||||
| Code | OCW, GCJ, HCF | OCW, GCJ, HCF | Same | ||
| FDA | |||||
| Classification | |||||
| Name | Endoscopic tissue approximation | ||||
| device | Endoscopic tissue approximation | ||||
| device | Same | ||||
| FDA Requlation | |||||
| Number | 21 CFR 876.1500 | 21 CFR 876.1500 | Same | ||
| Device | |||||
| description | A minimally invasive surgical device, | ||||
| which aids surgeons in closing trocar | |||||
| wounds following a laparoscopic | |||||
| procedure. | Designed to facilitate placement and | ||||
| withdrawal of suture loops to perform | |||||
| repair port entry punctures. | Same | ||||
| Indications for | |||||
| use | The Mediclose™ System is a single- | ||||
| use suturing device indicated for | |||||
| approximation of tissues and | |||||
| percutaneous suturing of port-site | |||||
| fascia wounds following laparoscopic | |||||
| surgery. | The WECK EFX Endo Fascial Closure | ||||
| System has application in laparoscopic | |||||
| procedures for approximation of tissues | |||||
| and percutaneous suturing for closing | |||||
| incision sites. | Equivalent | ||||
| Use environment | Operating room, sterile field | Operating room, sterile field | Same | ||
| Patient | |||||
| population | Patients undergoing abdominal | ||||
| laparoscopic surgery | Patients undergoing abdominal | ||||
| laparoscopic surgery | Same | ||||
| Sterile? | Yes, by ethylene oxide, SAL 10-6 | Yes, by radiation, SAL 10-6 | Different | ||
| Sterility Standard | ISO 11135: 2014/AMD 1:2018 | Unknown | N/A | ||
| Single use? | Yes | Yes | Same | ||
| Shelf Life | 12 months | Unknown | N/A |
5
| Comparison of Technological Characteristics | |||
|---|---|---|---|
| Characteristic | Subject device | Predicate device | Similarity |
| Mechanism of | |||
| Action | Manual manipulation and energy from | ||
| spring release | Manual manipulation | Similar | |
| Deployed through | |||
| Trocar Sleeve? | Yes | No, deployed through incision after | |
| removal of trocar sleeve | Different | ||
| Compatible with | |||
| different Trocar | |||
| Sleeves? | Yes, by means of mechanical adaptors | Unnecessary - device not deployed | |
| through trocar sleeve | Different | ||
| Compatible | |||
| Wound Size | Wounds made by 12 mm trocars and | ||
| maintained by 12 mm trocar sleeves | Wounds made by 10/12 or 15 mm | ||
| trocars (2 x models available with 'pilot | |||
| guides') | Different | ||
| Integral Needles? | Yes | Yes | Same |
| Suture Type/Size | PGLA Size 0 Braided Suture | PGLA Size 0 Braided Suture | Same |
| Suture pre- | |||
| loaded? | Yes | No, suture must be loaded prior to use | Different |
| Separate suture | |||
| passer? | No - needles and suture are integral to | ||
| the device | Yes | Different | |
| Prescription | |||
| device? | Yes, Rx only | Yes, Rx only | Same |
| Biocompatibility | |||
| Standards | ISO 10993-5:2009 | ||
| ISO 10993-10:2010 | |||
| ISO 10993-11:2017 | Unknown | N/A | |
| Bacterial | |||
| Endotoxin Test | LAL test | ||
| EP 2018: 20614 | Unknown | N/A | |
| Bench Tests | Mechanical test of critical items | ||
| Assembly tensile integrity tests | |||
| Adaptor tensile integrity tests | |||
| Suture tensile strength | |||
| Suture knot pull strength | |||
| Needle retention force | |||
| Operating button spring resistance | |||
| Passage through trocar tubes | |||
| Transportation test | Mechanical function test | ||
| Suture retention test | |||
| Destructive testing | Similar | ||
| Animal Tests | Porcine cadaver tests | ||
| In vivo porcine tests | Unknown | N/A | |
| Other Pre-clinical | |||
| Tests | Human tissue fascia tests | Unknown | N/A |
| Usability | |||
| Assessment | Yes | Unknown | N/A |
The subject device and the predicate device have many identical or similar properties or features. The differences that exist and are identified in the above table include:
- Sterilization method .
- . Use with/without trocar sleeve
- . Compatibility with trocar systems
- Suture loading
- . Suture passer
None of the identified differences introduce new aspects of safety or effectiveness.
6
Summary of non-clinical testing:
Non-clinical testing of the Mediclose™ System includes:
| Test Purpose | Standard | Acceptance criteria | Result | |
|---|---|---|---|---|
| Sterilization validation | ISO 11135:2020 1 | 5 samples | Sterile after half ETO cycle | Pass |
| Shelf life validation: | ISO 11607-2:2006 2 | |||
| See a) to e) below | ||||
| a) Transportation test | ISTA 3A:2018 3 | 1 x sample | Packaging is fully functional and | |
| undamaged | Pass | |||
| b) Sterile pack seal | ||||
| integrity | ASTM F1929-15 4 | 3 samples after ISTA | ||
| 3A test | No dye penetration | Pass | ||
| c) Sterile pack seal | ||||
| strength | EN 868-5:2019 5 | 24 samples after ISTA | ||
| 3A test | >1.5 N/15mm | Pass | ||
| d) Suture | ||||
| needle/thread | ||||
| strength | USP 6 | 5 samples after ISTA | ||
| 3A test | Average >14.7 N | |||
| Single result >4.41 N | Pass | |||
| e) Suture knot pull | ||||
| strength | USP | 10 samples after ISTA | ||
| 3A test | Average >38.2 N | Pass | ||
| Biocompatibility: | See a) to f) below: | |||
| a) Cytotoxicity | ISO 10993-5:2009 7 | Optical density | ≥70% of the control mean % | |
| viability | Pass | |||
| b) Sensitization | ISO 10993-10:2010 8 | Kligman maximization | ||
| 35 guinea pigs | Positive response in 0.5 degC | Pass | ||
| f) LAL bacterial | ||||
| endotoxicity | EP 01/2018: | |||
| 20614 10 | 3 samples | 15 N | Pass | |
| b) Mediclose folding | ||||
| part to handle tensile | Internal test protocol | 2 samples | >30 N | Pass |
| c) Mediclose folding | ||||
| part to handle | ||||
| compression | Internal test protocol | 3 samples | >30 N | Pass |
| d) Needle retention | ||||
| force | Internal test protocol | 5 samples average | >15 N 30 N | Pass |
| f) Adaptor security | ||||
| tensile | Internal test protocol | 3 samples per adaptor | ||
| type | >30 N | Pass | ||
| g) Operating button | ||||
| spring resistance | Internal test protocol | 3 samples | 2 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes 3 Packaged products for parcel delivery system shipment 70 kq or less |
4 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
5 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
6 Tensile strength
7 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
8 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
9 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity