(87 days)
Not Found
No
The device description and performance studies focus on mechanical function and surgical technique, with no mention of AI or ML.
No.
This device is used to close surgical wounds by passing sutures, which is a supportive function during a surgical procedure, not a therapeutic treatment itself.
No
The device description clearly states its purpose as "closing soft tissue layers (fascia, muscle and peritoneum) of a trocar wound following laparoscopic surgery," which is a surgical intervention, not a diagnostic process.
No
The device description explicitly details physical components (suture passer, guide, snare loops, accessory adaptor) and the performance studies are focused on mechanical testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to pass suture through soft tissue layers during laparoscopic surgery. This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is described as a set of instruments for closing soft tissue layers. This aligns with a surgical tool, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting markers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on mechanical testing and successful placement of suture in an animal model, which are relevant to the function of a surgical device, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
This product is intended to pass suture through soft tissue lavers (fascia, muscle and perioneum) of a trocar wound at the end of laparoscopic surgery.
It is to be used only by surgeons trained in endoscopic/laparoscopic surgery.
Product codes (comma separated list FDA assigned to the subject device)
OCW, HCF
Device Description
The CrossBow Fascial Closure System is a set of single-use instruments primarily intended for the use of closing soft tissue layers (fascia, muscle and peritoneum) of a trocar wound following laparoscopic surgery. The CrossBow Fascial Closure System has two basic components: (1) a suture passer component used to pass suture through the abdominal wall, and (2) a guide used to repeatedly direct the needle through the abdominal wall using visual markers to reference the needle puncture location off the inner wall of the abdomen. The guide has two deployable snare loops used to secure and retrieve the free ends of suture passed by the suture passer. The device also has an accessory adaptor to accommodate larger size port defects.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue layers (fascia, muscle and perioneum) of a trocar wound
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons trained in endoscopic/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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical performance bench testing (mechanical testing) was performed to demonstrate substantial equivalence to the predicate devices;
| Validation and/or
Verification Method | Acceptance Value/Criteria | Verification and
Validation Results |
|---|---|---|
| Mechanical Testing
(Needle Penetration) | To require comparable or less penetration
force than competitive devices | Acceptable |
| Mechanical Testing
(Snare Loop Integrity) | To exceed the strength of the expected
loading requirements | Acceptable |
| Mechanical Testing
(Needle Security in Passer) | To exceed the strength of the expected
loading requirements | Acceptable |
| Mechanical Testing
(Guide Suture Security) | To exceed the strength of the expected
loading requirements | Acceptable |
| Mechanical Testing
(Targeting & No. of Uses) | To provide accurate performance and
expected number of uses | Acceptable |
| Surgeon Validation Lab
(Animal model) | Successful placement of suture and
closure of defect | Acceptable |
The CrossBow Fascial Closure System tested met the predetermined acceptance criteria. Based on the results of the testing, the CrossBow Fascial Closure System is safe and effective for its intended use.
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.
Weck EFx Fascial Closure System, K132362
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 contains 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 1, 2017
SutureEase, Inc. Mr. Scott Heneveld Chief Operating Officer 1735 N First Street, Suite 300 San Jose, California 95112
Re: K172666
Trade/Device Name: CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCW, HCF Dated: August 28, 2017 Received: September 5, 2017
Dear Mr. Heneveld:
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. 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
1 of 1
510(k) Number (if known)
Device Name CrossBow Fascial Closure System
Indications for Use (Describe)
This product is intended to pass suture through soft tissue lavers (fascia, muscle and perioneum) of a trocar wound at the end of laparoscopic surgery.
It is to be used only by surgeons trained in endoscopic/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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
Traditional 510(k) Premarket Notification CrossBow Fascial Closure System
1. 510K SUMMARY
| Manufacturer | Contact Person |
|---|---|
| Suture Ease, Inc. | Scott Heneveld |
| 1735 N First Street, Suite 300 | COO |
| San Jose, California 95112 | (408) 459-7595 |
Trade Name: CrossBow Fascial Closure System Common / Usual Name: Endoscopic tissue approximation device Classification Name: Endoscope and Accessories Regulation Number: 21 CFR 876.1500 Device Class: II Product Code: HCF, OCW Predicate Device: Weck EFx Fascial Closure System, K132362
Device Description
The CrossBow Fascial Closure System is a set of single-use instruments primarily intended for the use of closing soft tissue layers (fascia, muscle and peritoneum) of a trocar wound following laparoscopic surgery. The CrossBow Fascial Closure System has two basic components: (1) a suture passer component used to pass suture through the abdominal wall, and (2) a guide used to repeatedly direct the needle through the abdominal wall using visual markers to reference the needle puncture location off the inner wall of the abdomen. The guide has two deployable snare loops used to secure and retrieve the free ends of suture passed by the suture passer. The device also has an accessory adaptor to accommodate larger size port defects.
4
Traditional 510(k) Premarket Notification CrossBow Fascial Closure System
Intended Use / Indications
-
1.1 Intended Use:
The device is intended to provide the function of aiding in the closure of the fascia/peritoneum at the trocar sites at the end of a laparoscopic procedure. -
1.2 Indication for Use:
- 1.2.1 This product is intended to pass suture through soft tissue layers (fascia. muscle and peritoneum) of a trocar wound at the end of laparoscopic surgery.
- 1.2.2 It is to be used only by surgeons trained in endoscopic/laparoscopic surgery.
-
1.3 Contra-Indications:
The device is subject to the following contra-indications:
- 1.3.1 This device is not intended for use where endoscopic techniques are contraindicated.
- 1.3.2 Do NOT use the CrossBow device where it is not possible to visualize the tip of the needle during insertion or removal.
- 1.3.3 The device is not intended for use when the minimum tissue thickness does not reach the markings on the guide component.
Summary of Non-Clinical Performance Data
The following non-clinical performance bench testing (mechanical testing) was performed to demonstrate substantial equivalence to the predicate devices;
| Validation and/or
Verification Method | Acceptance Value/Criteria | Verification and
Validation Results |
|---------------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------|
| Mechanical Testing
(Needle Penetration) | To require comparable or less penetration
force than competitive devices | Acceptable |
| Mechanical Testing
(Snare Loop Integrity) | To exceed the strength of the expected
loading requirements | Acceptable |
| Mechanical Testing
(Needle Security in Passer) | To exceed the strength of the expected
loading requirements | Acceptable |
| Mechanical Testing
(Guide Suture Security) | To exceed the strength of the expected
loading requirements | Acceptable |
| Mechanical Testing
(Targeting & No. of Uses) | To provide accurate performance and
expected number of uses | Acceptable |
| Surgeon Validation Lab
(Animal model) | Successful placement of suture and
closure of defect | Acceptable |
The CrossBow Fascial Closure System tested met the predetermined acceptance criteria. Based on the results of the testing, the CrossBow Fascial Closure System is safe and effective for its intended use.
5
Traditional 510(k) Premarket Notification CrossBow Fascial Closure System
Biocompatibility
The biocompatibility evaluation for the CrossBow Fascial Closure System was conducted in accordance with the International Standard ISO 10993-1: "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process", as recognized by FDA.
Biomaterial testing was performed on the device components individually and the following tests were conducted on the finished, completed device after gamma sterilization:
- Cytotoxicity ●
- Irritation ●
- Sensitization .
- Material Mediated Pyrogenicity ●
- Hemocompatibility
According to ISO 10993-1: "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" the CrossBow Fascial Closure System is categorized as:
- Externally Communicating
- . Blood Contacting
- Less than 24 hours
Conclusion
The CrossBow Fascial Closure System is substantially equivalent in intended use and fundamental scientific technology as the Weck EFx Endo Fascial Closure System (K132362). The design differences have been demonstrated to not affect safety or effectiveness or raise new issues of safety or effectiveness.