(484 days)
Not Found
No
The device description details a purely mechanical, hand-operated suture placement device with no mention of computational processing, data analysis, or learning algorithms. The performance studies are bench-top tests of mechanical function and biocompatibility, not validation of AI/ML performance.
No
The device is described as a nonpowered, hand-operated suture placement device used to facilitate the placement of stitches for approximating soft tissue and prosthetic materials. It is an instrument used during a procedure, not a device that directly treats a disease or condition.
No
Explanation: The device is described as a "suture placement device" used for "approximation of soft tissue and prosthetic materials." Its function involves placing stitches, which is a therapeutic rather than a diagnostic action.
No
The device description clearly details a physical, hand-operated surgical instrument with mechanical components (jaws, needles, knobs, lever). It is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "approximation of soft tissue and prosthetic materials." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details a mechanical, hand-operated device for placing sutures. It does not involve analyzing biological samples (blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for tissue repair.
N/A
Intended Use / Indications for Use
The MD™ MATTRESS Suture Placement Device is indicated for use in the approximation of soft tissue and prosthetic materials.
Product codes
GCJ, GAS
Device Description
The MD™ MATTRESS Device is a nonpowered, hand-operated suture placement device that facilitates placement of a stitch, for example horizontal mattress stitches. Each sterile package contains one single-patient-use MD™ MATTRESS Device. The lavender device tip has an integrated tissue jaw incorporating a jaw width indicator that identifies the jaw when it is embedded in tissue. Two curved needles emerge from their protective compartments to advance across the tissue jaw, rotating about the circular needle axle indicator to engage needle caps with attached suture that are loaded into specialized needle cap compartments. An angulation indicator on the tip and the device shaft depicts the direction of the device tip angle, which is adjusted using the white angulation knob. The embossed arrow and word "IN" indicate the direction the device tip moves when the angulation knob is rotated clockwise; the device tip can be angled up to approximately 15° in either direction, as indicated by the 3 embossed radial lines in the angulation indicator The lavender rotational knob can be rotated to orient the device shaft and tip into one of six distinct positions. The rotational knob has an integrated eyelet, for stabilizing a suture tube with indwelling suture, and an indicator fin that is aligned with the device tip tissue jaw. Fully squeezing the lavender lever toward the white handle causes both curved needles in the device tip to advance across the tissue jaw toward the needle cap compartments. Fully releasing the lever causes both needles and their engaged needle caps with attached suture to retract back across the tissue gap, pulling both suture ends through the targeted tissue within the jaw. Fully squeezing the lever again causes the needles and engaged needle caps with attached suture to advance back into their corresponding needle cap compartments, and an internal mechanism alternates the device into its rearming mode. Fully releasing the lever again causes the needles to retract into their protective compartments, leaving the needle caps and attached suture ends in the needle cap compartments. Subsequently squeezing and releasing the lever will repeat the pickup and rearm cycle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Any patient requiring the approximation of soft tissue or prosthetic materials.
Intended User / Care Setting
Suitable for use in any environment where surgical procedures occur under the supervision of a physician. Compatible with open surgeries, smaller access/minimally invasive surgeries, and surgery through a cannula or other access ports with seals to maintain positive CO2 pressure at the surgical site.
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)
Bench top performance testing was conducted to verify that the MD™ MATTRESS Device will perform as intended and to ensure the device will perform equivalently to the predicate device.
Non-clinical tests included:
- Functional Design Verification and Validation Testing to ensure the Design Input Requirements were met.
- Biocompatibility per ISO 10993-1:2018 and in accordance with FDA Guidance for Industry Use of International Standard ISO 10993-1, "Biological evaluation of medical device – Part 1: Evaluation and testing within a risk management process, September 4, 2020. The MD™ MATTRESS Device can be classified as an externally communicating medical device that has limited contact (≤24 hours) with tissue. The battery of testing included:
- Chemical characterization
- Cytotoxicity
- Sensitization
- Irritation
- Material-mediated pyrogenicity
- Acute systemic toxicity
- Packaging/Shelf-life Testing per ISO 11607-1:2019 demonstrating a 2 year shelf life.
All results met the performance and risk-based acceptance criteria.
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
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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
January 12, 2024
LSI Solutions, Inc. Christopher Miller Executive Director of Regulatory Affairs and Quality 7796 Victor-Mendon Rd Victor, New York 14564
Re: K222783
Trade/Device Name: MD Mattress Suture Placement Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Codes: GCJ, GAS Dated: June 21, 2023 Received: June 22, 2023
Dear Christopher Miller:
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" (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).
1
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 QS 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, Tek N. v signed by Tek N Lamichhane -S Date: 2024.01.12 17:17:45 -05'00 Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K222783
Device Name MD™ MATTRESS Suture Placement Device
Indications for Use (Describe)
The MD™ MATTRESS Suture Placement Device is indicated for use in the approximation of soft tissue and prosthetic materials.
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
| Submitted By: | LSI SOLUTIONS, Inc.
7796 Victor-Mendon Road
Victor, NY 14564 |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Christopher B. Miller
Executive Director of Regulatory Affairs and Quality
Phone: (585) 869-6665
Fax: (585) 742-8086
Email: cmiller@lsisolutions.com |
| Date Prepared: | 10 JAN 2024 |
| Trade Name: | MD™ MATTRESS Suture Placement Device |
| Common Name: | Needle Guide |
| Classification Name: | Endoscope and Accessories (per 21 CFR 876.1500) |
| Classification Regulation: | 21 CFR 876.1500 |
| Product Code: | GCJ (Primary Product Code)
GAS (Secondary Product Code) |
4
Device Classification: Class II
Predicate Device:
RD180® - THE RUNNING DEVICE® (Cleared under Premarket Notification K100593)
Device Description
The MD™ MATTRESS Device is a nonpowered, hand-operated suture placement device that facilitates placement of a stitch, for example horizontal mattress stitches. Each sterile package contains one single-patient-use MD™ MATTRESS Device. The lavender device tip has an integrated tissue jaw incorporating a jaw width indicator that identifies the jaw when it is embedded in tissue. Two curved needles emerge from their protective compartments to advance across the tissue jaw, rotating about the circular needle axle indicator to engage needle caps with attached suture that are loaded into specialized needle cap compartments. An angulation indicator on the tip and the device shaft depicts the direction of the device tip angle, which is adjusted using the white angulation knob. The embossed arrow and word "IN" indicate the direction the device tip moves when the angulation knob is rotated clockwise; the device tip can be angled up to approximately 15° in either direction, as indicated by the 3 embossed radial lines in the angulation indicator The lavender rotational knob can be rotated to orient the device shaft and tip into one of six distinct positions. The rotational knob has an integrated eyelet, for stabilizing a suture tube with indwelling suture, and an indicator fin that is aligned with the device tip tissue jaw. Fully squeezing the lavender lever toward the white handle causes both curved needles in the device tip to advance across the tissue jaw toward the needle cap compartments. Fully releasing the lever causes both needles and their engaged needle caps with
5
attached suture to retract back across the tissue gap, pulling both suture ends through the targeted tissue within the jaw. Fully squeezing the lever again causes the needles and engaged needle caps with attached suture to advance back into their corresponding needle cap compartments, and an internal mechanism alternates the device into its rearming mode. Fully releasing the lever again causes the needles to retract into their protective compartments, leaving the needle caps and attached suture ends in the needle cap compartments. Subsequently squeezing and releasing the lever will repeat the pickup and rearm cycle.
While the MD™ MATTRESS Device is used for the placement of MD™ QUICK LOAD® SURGICAL SUTURES, this premarket submission does not include a request for clearance of suture materials since MD™ QUICK LOAD® SURGICAL SUTURE is listed on FDA's Establishment Registration and Device Listing database (K203081).
One (1) MD™ MATTRESS Device is provided per package, and the MD™ MATTRESS Device is intended to facilitate the placement of multiple sutures through tissue and prosthetic materials.
Intended Use
The MD™ MATTRESS Device is intended for use in the approximation of soft tissue and prosthetic materials.
Indications for Use
The MD™ MATTRESS Suture Placement Device is indicated for use in the approximation of soft tissue and prosthetic materials.
6
Technological characteristics (comparison to Predicate Device)
Both the predicate RD180® Device and the subject MD™ MATTRESS Device have the same intended use: "Intended for use in the approximation of soft tissue and prosthetic materials." The predicate RD180® Device is "indicated for use in the approximation of soft tissue and prosthetic materials," and LSI recommends its use with 2-0 polyester suture, among other suture types. The subject MD™ MATTRESS Device has similar indications. The MD™ MATTRESS Device is "indicated for use in the approximation of soft tissue and prosthetic materials." The subject and predicate devices are both designed for sewing suture on similar technical principles. Both devices are single-patient-use, nonpowered, hand-operated devices that incorporate a leverdriven mechanism that pierces needles through tissue, picks up suture, and pulls the suture back through the tissue to facilitate placing a stitch.
Both the subject and predicate devices operate on the same principle to accomplish the tasks the devices are intended to perform. These tasks include: loading suture needle caps into the device tip; passing the device tip through the surgical access site (optionally through a cannula if appropriate); selecting the desired device tip position over a target site; firing needles through tissue and pulling the suture back through the tissue; rearming the device to allow for placement of additional tissue bites (as deemed appropriate by the surgeon); and removing the suture needle caps from the needles. Both the subject and predicate devices are provided sterile, after sterilization with ethylene oxide such that a minimum lethality of 10% is achieved. The predicate RD180® Device is a stainless steel and polymer suture delivery device. The MD™ MATTRESS Device is made from similar, often identical, materials. Both devices conform to the requirements of ISO 10993. The predicate device is packaged in a rigid thermoformed PETG
7
blister tray with a Tyvek® cover. The subject device is packaged in the similar configuration with similar materials: a blue-tint PETG tray and retainer inserted into a Tyvek®/Nylon pouch.
The MD™ MATTRESS Device and the predicate RD180® Device are substantially equivalent. The subject and predicate devices are comparable, and the differences do not introduce any new risks, and have no negative impact on the safety and efficacy of the MD™ MATTRESS Device.
A summary of the comparison between the subject MD™ MATTRESS Device and predicate RD180® Device is provided in the table below.
| Table 6: Substantial Equivalence Comparison | ||
|---|---|---|
| Subject Area | Predicate Device: | |
| RD180® - THE RUNNING | ||
| DEVICE® | Subject Device: | |
| MD™ MATTRESS Device | ||
| 510(k) Number: | K100593 | K222783 |
| Device Class: | II | II |
| Classification | ||
| Regulation: | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Product Code: | GCJ | GCJ |
| Intended Use: | Intended for use in the | |
| approximation of soft tissue and | ||
| prosthetic materials. | Intended for use in the | |
| approximation of soft tissue and | ||
| prosthetic materials. | ||
| Indications for Use: | Indicated for use in the | |
| approximation of soft tissue and | ||
| prosthetic materials. | Indicated for use in the | |
| approximation of soft tissue and | ||
| prosthetic materials. |
8
| Table 6: Substantial Equivalence Comparison | ||
|---|---|---|
| Subject Area | Predicate Device: | |
| RD180® - THE RUNNING | ||
| DEVICE® | Subject Device: | |
| MD™ MATTRESS Device | ||
| Single Use/ | ||
| Reusable: | Single Use | Single Use |
| Design: | Device tip (including a tissue | |
| jaw, single straight needle, and a | ||
| needle cap compartment) | Device tip (including a tissue | |
| jaw, jaw width indicator, dual | ||
| curved needles, needle axle | ||
| indicator, needle cap | ||
| compartments, and an | ||
| angulation indicator) | ||
| Device shaft | Device shaft (including an | |
| angulation knob, rotational knob | ||
| with an integrated eyelet and | ||
| indicator fin) | ||
| Pink lever | Lavender lever | |
| White handle | White handle | |
| Table 6: Substantial Equivalence Comparison | ||
| Subject Area | Predicate Device: | |
| RD180® - THE RUNNING | ||
| DEVICE® | Subject Device: | |
| MD™ MATTRESS Device | ||
| Technological | ||
| Characteristics: | Nonpowered, hand-operated; incorporating a lever-driven | |
| mechanism utilizing needle-and- | ||
| needle-cap technology to place | ||
| suture through tissue or | ||
| prosthetic materials using a | ||
| single straight needle. |
The predicate device does not
contain any articulation or
rotational knobs or functions. | Nonpowered, hand-operated; incorporating a lever-driven
mechanism utilizing needle-and-
needle-cap technology to place
suture through tissue or
prosthetic materials using dual
curved needles.
COMPARABLE
The subject device contains an
articulation knob, which can be
used to angulate the device tip
inward or outward, and a
rotational knob, which enables
the device shaft and
correspondingly the device tip
to rotate through six distinct
positions. |
| Target Population: | Any patient requiring the
approximation of soft tissue or
prosthetic materials. | Any patient requiring the
approximation of soft tissue or
prosthetic materials.
SAME |
| Table 6: Substantial Equivalence Comparison | | |
| Subject Area | Predicate Device:
RD180® - THE RUNNING
DEVICE® | Subject Device:
MD™ MATTRESS Device |
| Environment of
Use: | Suitable for use in any
environment where surgical
procedures occur under the
supervision of a physician.
Compatible with open surgeries,
smaller access/minimally
invasive surgeries, and surgery
through a cannula or other
access ports with seals to
maintain positive CO2 pressure
at the surgical site. | Suitable for use in any
environment where surgical
procedures occur under the
supervision of a physician.
Compatible with open surgeries,
smaller access/minimally
invasive surgeries, and surgery
through a cannula or other
access ports with seals to
maintain positive CO2 pressure
at the surgical site. |
| Sterility | To be sterilized with ethylene
oxide such that a minimum
lethality of 10-6 is achieved. | To be sterilized with ethylene
oxide such that a minimum
lethality of 10-6 is achieved. |
| Materials and
Biocompatibility | Comprising stainless steel and
polymers.
Conforms to the requirements of
ISO 10993-1:2009. | Comprising stainless steel and
polymers.
Conforms to the requirements of
ISO 10993-1:2018. |
| Packaging | Packaged in a rigid
thermoformed PETG tray with a
Tyvek® cover. | Packaged in a PETG tray and
retainer lid which are sealed in a
Tyvek®/Nylon pouch. |
9
10
Performance Testing Summary
Bench top performance testing was conducted to verify that the MD™ MATTRESS Device will perform as intended and to ensure the device will perform equivalently to the predicate device.
11
The following non-clinical tests were conducted, and all results met the performance and riskbased acceptance criteria:
- . Functional Design Verification and Validation Testing to ensure the Design Input Requirements were met.
- Biocompatibility per ISO 10993-1:2018 and in accordance with FDA Guidance for . Industry Use of International Standard ISO 10993-1, "Biological evaluation of medical device – Part 1: Evaluation and testing within a risk management process, September 4, 2020. The MD™ MATTRESS Device can be classified as an externally communicating medical device that has limited contact (≤24 hours) with tissue. The battery of testing included:
- Chemical characterization O
- Cytotoxicity o
- Sensitization O
- Irritation o
- Material-mediated pyrogenicity o
- 0 Acute systemic toxicity
- . Packaging/Shelf-life Testing per ISO 11607-1:2019 demonstrating a 2 year shelf life.
Clinical Testing
Not applicable. Neither the predicate nor the subject product require clinical testing. The substantial performance testing discussed above confirms the reliability and excellent performance of the MD™ MATTRESS Device. The performance testing included multiple experiments that do not require clinical testing in patients.
12
Substantial Equivalence
The subject device and predicate device have the same intended use and technological characteristics. Non-clinical performance data has demonstrated the subject device is substantially equivalent to the predicate device.
Conclusion
The subject MD™ MATTRESS Device is substantially equivalent to the predicate RD180® Device, submitted under Premarket Notification K100593 and cleared in 2010. Extensive testing demonstrates that the proposed product consistently provides excellent suture placement and can be dependably manufactured. The MD™ MATTRESS Device will be safe and effective for the approximation of soft tissue and prosthetic materials.